This document outlines procedures for sampling, testing, and approving or rejecting raw materials. It describes how quality control receives notification of raw material deliveries and assigns sampling. Sampling executives verify details, select containers for sampling, and collect composite samples from containers to bring for testing according to specifications. If samples pass tests, materials are approved. If samples fail, an investigation is opened. The process is described for solids in containers and liquids in tankers.
This document summarizes guidelines for media fill validation and USFDA process validation approaches. It discusses media fill validation, including why it is required, how to conduct media fill tests, parameters that affect sterility, and requalification requirements. It provides details on media fill procedures for liquid, powder, and lyophilized products. Frequency of media fills depends on production batch size, with more runs required for initial qualification and after certain changes. The document also introduces the USFDA's process validation lifecycle approach, which focuses on validating processes throughout the product lifecycle rather than just at startup.
This document discusses vendor audits for packaging materials. It defines a vendor audit as a way for pharmaceutical companies to inspect and evaluate a vendor's quality management system and practices. The objectives of a vendor audit are to ensure contracts are executed properly and identify risks, cost savings, and process improvements. The document outlines key steps in conducting a vendor audit, including preparing an audit plan, inspecting facilities and documentation, and writing an evaluation report. It also provides details on auditing packaging material vendors, such as checking storage areas, materials, and supplier qualifications.
presentation of sampling , testing ,release and rejection of Raw materialsshaik malangsha
I hope this ppt would be help to improve & make aware about better sampling , testing ,release and rejection of Raw materials . I believe if once ill go through this ppt it ill defiantly help to improve our RM procedure. If any clarifications pls. mail me at shkrahul42@gmail.com
Raw materials include all materials used in manufacturing a finished product, whether present in the final product or not. They must meet defined purchase specifications. Key steps in purchasing raw materials include requisition, supplier selection, quotation, order placement, receipt, and payment. Proper storage conditions must be maintained based on product requirements. Vendors are selected and qualified to ensure a consistent supply of materials meeting quality standards. Receipt, storage, and sampling of materials are controlled through standard operating procedures.
AUDITING OF AUALITY ASSURANCE AND ENGINEERING DEPARTMENT HemlataMore3
This document discusses auditing of quality assurance and engineering departments. It defines quality audit and discusses the importance of quality maintenance through pillars such as focused improvement and autonomous maintenance. Critical systems like HVAC, WFI, and ETP are explained. HVAC is described as maintaining temperature and air flow. Validation of HVAC, WFI, and ETP systems is outlined. The document provides references for further information.
This presentation is basic knowledge about the aseptic processing and media fill validation in pharmaceutical industry and media fill procedure. How to validate aseptic process in the powder drug products , data guidance and record for media fill validation.
1. In-process quality control (IPQC) involves monitoring and adjusting manufacturing processes to ensure products meet specifications from raw materials to finished products.
2. IPQC includes tests and inspections of materials, equipment, processes, and operations during production to check for accuracy, uniformity, and consistency within and between batches.
3. Common in-process controls for pharmaceuticals involve testing attributes like weight, content of active ingredients, disintegration, and checking for contamination.
The document discusses in-process quality control (IPQC) during pharmaceutical packaging operations. It describes various IPQC tests that should be performed at the start of each packaging batch, including protruding product sensor tests, pin hole detector tests, and leak tests. It also discusses barcode sensor tests that should be done every half hour to check cartons and leaflets. The key goal of IPQC is to provide early warnings for any quality issues during packaging and help ensure the packaged drugs maintain standards of identity, strength, quality and purity until consumption.
This document summarizes guidelines for media fill validation and USFDA process validation approaches. It discusses media fill validation, including why it is required, how to conduct media fill tests, parameters that affect sterility, and requalification requirements. It provides details on media fill procedures for liquid, powder, and lyophilized products. Frequency of media fills depends on production batch size, with more runs required for initial qualification and after certain changes. The document also introduces the USFDA's process validation lifecycle approach, which focuses on validating processes throughout the product lifecycle rather than just at startup.
This document discusses vendor audits for packaging materials. It defines a vendor audit as a way for pharmaceutical companies to inspect and evaluate a vendor's quality management system and practices. The objectives of a vendor audit are to ensure contracts are executed properly and identify risks, cost savings, and process improvements. The document outlines key steps in conducting a vendor audit, including preparing an audit plan, inspecting facilities and documentation, and writing an evaluation report. It also provides details on auditing packaging material vendors, such as checking storage areas, materials, and supplier qualifications.
presentation of sampling , testing ,release and rejection of Raw materialsshaik malangsha
I hope this ppt would be help to improve & make aware about better sampling , testing ,release and rejection of Raw materials . I believe if once ill go through this ppt it ill defiantly help to improve our RM procedure. If any clarifications pls. mail me at shkrahul42@gmail.com
Raw materials include all materials used in manufacturing a finished product, whether present in the final product or not. They must meet defined purchase specifications. Key steps in purchasing raw materials include requisition, supplier selection, quotation, order placement, receipt, and payment. Proper storage conditions must be maintained based on product requirements. Vendors are selected and qualified to ensure a consistent supply of materials meeting quality standards. Receipt, storage, and sampling of materials are controlled through standard operating procedures.
AUDITING OF AUALITY ASSURANCE AND ENGINEERING DEPARTMENT HemlataMore3
This document discusses auditing of quality assurance and engineering departments. It defines quality audit and discusses the importance of quality maintenance through pillars such as focused improvement and autonomous maintenance. Critical systems like HVAC, WFI, and ETP are explained. HVAC is described as maintaining temperature and air flow. Validation of HVAC, WFI, and ETP systems is outlined. The document provides references for further information.
This presentation is basic knowledge about the aseptic processing and media fill validation in pharmaceutical industry and media fill procedure. How to validate aseptic process in the powder drug products , data guidance and record for media fill validation.
1. In-process quality control (IPQC) involves monitoring and adjusting manufacturing processes to ensure products meet specifications from raw materials to finished products.
2. IPQC includes tests and inspections of materials, equipment, processes, and operations during production to check for accuracy, uniformity, and consistency within and between batches.
3. Common in-process controls for pharmaceuticals involve testing attributes like weight, content of active ingredients, disintegration, and checking for contamination.
The document discusses in-process quality control (IPQC) during pharmaceutical packaging operations. It describes various IPQC tests that should be performed at the start of each packaging batch, including protruding product sensor tests, pin hole detector tests, and leak tests. It also discusses barcode sensor tests that should be done every half hour to check cartons and leaflets. The key goal of IPQC is to provide early warnings for any quality issues during packaging and help ensure the packaged drugs maintain standards of identity, strength, quality and purity until consumption.
The document discusses the FDA's 2011 guidance on a lifecycle approach to process validation. It begins by explaining the differences between the 1987 guidance and the 2011 guidance, which focuses on three stages: process design, process qualification, and continued process verification. The document then goes into detail about each stage, explaining the goals and key activities of each stage. It provides details on what should be included in process qualification protocols, execution of process qualification, and ongoing activities in continued process verification.
Auditing of vendors and production departmentPRANJAY PATIL
The document discusses vendor audits in the pharmaceutical industry. It provides details on the objectives, parameters, and steps of conducting a vendor audit. The key points are:
- Vendor audits assess a vendor's quality management system, practices, documentation, and adherence to standards to ensure their products and services meet requirements.
- Important parameters reviewed include ISO certifications, manufacturing facilities, packaging and labeling standards, and data handling procedures.
- The goals are to evaluate quality control measures and management commitment to quality standards required by regulations.
- Conducting vendor audits helps reduce costs and risks by gaining insight into supplier processes and compliance.
Definition
Regulatory Bodies that oversee Pharmaceutical Waste Management
Type of Waste
Methods of product disposal
Waste product Disposal Procedure
Scales of product disposal
Pharmaceutical Waste Management Guidelines
Records
This document outlines procedures for clearing and cleaning production lines before changing products to prevent mix-ups. It details:
- Removing all materials from the previous product, including documents. Supervisors ensure the area is cleared.
- Cleaning the area thoroughly once cleared. Two types of cleaning are described: batch-to-batch and product-to-product.
- Filling clearance documents and having QA personnel inspect and sign off before giving line clearance to proceed with the next product. Temperature, humidity and cleaning standards must be met.
The document discusses calculation of yields, production record review, and change control in the pharmaceutical industry. It provides definitions and requirements for theoretical yield, actual yield, and practical yield calculation. It states that all production records must be reviewed and approved before batch release. Any unexplained discrepancies or failed batches must be investigated. The document also defines minor, major, and critical changes and the proper change control process, including documenting the request, assessing the change, planning implementation, verifying the impact, implementing, and closing out the change.
USFDA guidelines on process validation a life cycle approachRx Ayush Sharma
The document summarizes the US FDA's 2011 guidance on process validation, which outlines a lifecycle approach. It discusses the three stages of process validation according to the guidance: (1) Process Design which defines the commercial process based on development, (2) Process Qualification which evaluates the process's capability for commercial manufacturing, and (3) Continued Process Verification which gains ongoing assurance that the process remains in control during routine production. The lifecycle approach integrates validation strategies from previous guidelines and emphasizes continual process improvement, understanding sources of variation, and controlling variation to ensure consistent quality.
CHAPTER-1 Information Gathering and Administration.pdfDr. Dinesh Mehta
During the audit, information relevant to the objectives, scope and criteria, including information on interfaces between functions, activities and processes, should be collected by appropriate sampling and should be verified.
The document discusses auditing of microbiology laboratories. It provides definitions of auditing and outlines areas that should be assessed such as laboratory layout, equipment and facilities, documentation practices, and manufacturing processes. Key areas that are important for auditors to evaluate include laboratory organization, sampling procedures, media preparation, equipment maintenance, method validation, documentation, biosafety, and proficiency testing. The role of the microbiology laboratory in auditing sterile product facilities is also described.
The document discusses validation of analytical methods used in cleaning validation. It covers parameters assessed in analytical method validation like specificity, linearity, range, accuracy, precision, LOD, LOQ. It also discusses method validation, cleaning validation, levels of cleaning, cleaning process validation, typical analytical procedures and their applicability. Key aspects of validation covered include equipment and personnel qualification, microbiological considerations, documentation, sampling, rinsing, rinse samples, detergents used and establishment of acceptable limits.
This document discusses in-process quality assurance in pharmaceutical manufacturing. It defines quality as meeting consumer needs and outlines how quality is built into the manufacturing process through controls like following good manufacturing practices, input material control, process control, in-process checks, cross-checking, and product release controls. The document explains that in-process quality assurance is important to ensure products are consistently manufactured to quality standards by guiding operators about any deviations observed during production. It provides examples of in-process checks for various unit operations like blending, compression, and coating. The overall goal of in-process quality assurance is to reduce batch rejections and reprocessing by adopting controls that build quality into each stage of the manufacturing process.
The document summarizes ICH Q10, which provides a harmonized model for a pharmaceutical quality system throughout the lifecycle of a product. It describes the contents and sections of ICH Q10, including management responsibility, continual improvement of process performance and product quality, and continual improvement of the pharmaceutical quality system. The goal is to establish an effective quality management system for the pharmaceutical industry and enhance the quality and availability of medicines.
This document discusses good manufacturing practices for manufacturing operations and controls in the pharmaceutical industry. It covers several key topics:
1. Sanitation of manufacturing premises is important to ensure good hygiene of facilities, equipment, processes, and personnel. Cleaning and validation procedures should be established and records maintained.
2. Proper controls must be established to prevent mix-ups and cross-contamination during production. This includes separation of products, labeling, cleaning procedures, and qualified personnel.
3. Waste and scrap from manufacturing must be properly handled, collected, stored, and disposed of according to established guidelines. Hazardous and pharmaceutical wastes require special treatment and disposal.
This document discusses vendor qualification and product returns and recalls in the pharmaceutical industry. It provides definitions and guidelines for recall classification, initiation, and responsibilities of recalling firms. It also discusses vendor qualification categories and criteria for selection. The key points are that recall means removing violating products from the market, while return means sending unused products back. Firms must qualify vendors on various criteria like quality, delivery, and facilities to ensure consistent product quality.
CLEANING VALIDATION for M.pharm and industry personabhishek pandey
YOU CAN EASY WAY TO UNDERSTAND A PROCESS AND ANLYTICAL METHOD OF CLEANING VALIDATION
Cleaning validation is the methodology used to assure that a cleaning process removes residues of the active pharmaceutical ingredients of the product manufactured in a piece of equipment, the cleaning aids utilized in the cleaning process and the microbial attributes.[1] All residues are removed to predetermined levels to ensure the quality of the next product manufactured is not compromised by waste from the previous product and the quality of future products using the equipment, to prevent cross-contamination and as a GMP requirement.
The U.S. Food and Drug Administration (FDA) has strict regulation about the cleaning validation. For example, FDA requires firms to have written general procedures on how cleaning processes will be validated. Also, FDA expects the general validation procedures to address who is responsible for performing and approving the validation study, the acceptance criteria, and when revalidation will be required. FDA also require firms to conduct the validation studies in accordance with the protocols and to document the results of studies.The valuation of cleaning validation is also regulated strictly, which usually mainly covers the aspects of equipment design,cleaning process written, analytical methods and sampling. Each of these processes has their related strict rules and requirements. Regarding to the establishment of limits, FDA does not intend to set acceptance specifications or methods for determining whether a cleaning process is validated. But some limits that have been mentioned by industry include analytical detection levels such as 10 PPM, biological activity levels such as 1/1000 of the normal therapeutic dose and organoleptic levels.[2][3][4]
Cleaning Validation in the context of Active Pharmaceutical Ingredient manufacture may be defined as: "The process of providing documented evidence that the cleaning methods employed within a facility consistently controls potential carryover of product (including intermediates and impurities), cleaning agents and extraneous material into subsequent product to a level which is below predetermined levels".
Manufacturing operations and control must ensure identity, strength, safety, and purity of products. Facilities must be properly sanitized and cleaned to prevent contamination and mix-ups. During packaging, lines must be cleared properly and monitoring must ensure integrity of finished products. In-process and finished product testing must meet specifications before final product release. Strict controls over materials, personnel, equipment, and facilities help guarantee quality and prevent issues like cross contamination.
In this slide contains Introduction, levels of cleaning, mechanism, sampling method of cleaning validation.
Presented by: P. VENKATESH (Department of pharmaceutical analysis).RIPER, anantapur
The document outlines the standard operating procedure for sampling, testing, and releasing or rejecting finished products. It describes the steps taken by quality control personnel, including receiving sampling requests, collecting and labeling samples, distributing samples for analysis, testing samples according to procedures, reviewing results, and releasing or rejecting batches based on specifications. Key steps involve sampling from containers, analyzing samples in the chemical and instrument labs, approving results, and recording the final status of batches.
The document outlines the standard operating procedure for sampling, testing, and releasing or rejecting finished products. It describes the steps taken by quality control personnel including receiving sampling requests, collecting and labeling samples, distributing samples for analysis, testing samples according to procedures, reviewing results, and releasing or rejecting batches based on specifications. Key steps involve sampling from containers, analyzing samples in the chemical and instrument labs, approving results, and determining the batch's status.
The document discusses the FDA's 2011 guidance on a lifecycle approach to process validation. It begins by explaining the differences between the 1987 guidance and the 2011 guidance, which focuses on three stages: process design, process qualification, and continued process verification. The document then goes into detail about each stage, explaining the goals and key activities of each stage. It provides details on what should be included in process qualification protocols, execution of process qualification, and ongoing activities in continued process verification.
Auditing of vendors and production departmentPRANJAY PATIL
The document discusses vendor audits in the pharmaceutical industry. It provides details on the objectives, parameters, and steps of conducting a vendor audit. The key points are:
- Vendor audits assess a vendor's quality management system, practices, documentation, and adherence to standards to ensure their products and services meet requirements.
- Important parameters reviewed include ISO certifications, manufacturing facilities, packaging and labeling standards, and data handling procedures.
- The goals are to evaluate quality control measures and management commitment to quality standards required by regulations.
- Conducting vendor audits helps reduce costs and risks by gaining insight into supplier processes and compliance.
Definition
Regulatory Bodies that oversee Pharmaceutical Waste Management
Type of Waste
Methods of product disposal
Waste product Disposal Procedure
Scales of product disposal
Pharmaceutical Waste Management Guidelines
Records
This document outlines procedures for clearing and cleaning production lines before changing products to prevent mix-ups. It details:
- Removing all materials from the previous product, including documents. Supervisors ensure the area is cleared.
- Cleaning the area thoroughly once cleared. Two types of cleaning are described: batch-to-batch and product-to-product.
- Filling clearance documents and having QA personnel inspect and sign off before giving line clearance to proceed with the next product. Temperature, humidity and cleaning standards must be met.
The document discusses calculation of yields, production record review, and change control in the pharmaceutical industry. It provides definitions and requirements for theoretical yield, actual yield, and practical yield calculation. It states that all production records must be reviewed and approved before batch release. Any unexplained discrepancies or failed batches must be investigated. The document also defines minor, major, and critical changes and the proper change control process, including documenting the request, assessing the change, planning implementation, verifying the impact, implementing, and closing out the change.
USFDA guidelines on process validation a life cycle approachRx Ayush Sharma
The document summarizes the US FDA's 2011 guidance on process validation, which outlines a lifecycle approach. It discusses the three stages of process validation according to the guidance: (1) Process Design which defines the commercial process based on development, (2) Process Qualification which evaluates the process's capability for commercial manufacturing, and (3) Continued Process Verification which gains ongoing assurance that the process remains in control during routine production. The lifecycle approach integrates validation strategies from previous guidelines and emphasizes continual process improvement, understanding sources of variation, and controlling variation to ensure consistent quality.
CHAPTER-1 Information Gathering and Administration.pdfDr. Dinesh Mehta
During the audit, information relevant to the objectives, scope and criteria, including information on interfaces between functions, activities and processes, should be collected by appropriate sampling and should be verified.
The document discusses auditing of microbiology laboratories. It provides definitions of auditing and outlines areas that should be assessed such as laboratory layout, equipment and facilities, documentation practices, and manufacturing processes. Key areas that are important for auditors to evaluate include laboratory organization, sampling procedures, media preparation, equipment maintenance, method validation, documentation, biosafety, and proficiency testing. The role of the microbiology laboratory in auditing sterile product facilities is also described.
The document discusses validation of analytical methods used in cleaning validation. It covers parameters assessed in analytical method validation like specificity, linearity, range, accuracy, precision, LOD, LOQ. It also discusses method validation, cleaning validation, levels of cleaning, cleaning process validation, typical analytical procedures and their applicability. Key aspects of validation covered include equipment and personnel qualification, microbiological considerations, documentation, sampling, rinsing, rinse samples, detergents used and establishment of acceptable limits.
This document discusses in-process quality assurance in pharmaceutical manufacturing. It defines quality as meeting consumer needs and outlines how quality is built into the manufacturing process through controls like following good manufacturing practices, input material control, process control, in-process checks, cross-checking, and product release controls. The document explains that in-process quality assurance is important to ensure products are consistently manufactured to quality standards by guiding operators about any deviations observed during production. It provides examples of in-process checks for various unit operations like blending, compression, and coating. The overall goal of in-process quality assurance is to reduce batch rejections and reprocessing by adopting controls that build quality into each stage of the manufacturing process.
The document summarizes ICH Q10, which provides a harmonized model for a pharmaceutical quality system throughout the lifecycle of a product. It describes the contents and sections of ICH Q10, including management responsibility, continual improvement of process performance and product quality, and continual improvement of the pharmaceutical quality system. The goal is to establish an effective quality management system for the pharmaceutical industry and enhance the quality and availability of medicines.
This document discusses good manufacturing practices for manufacturing operations and controls in the pharmaceutical industry. It covers several key topics:
1. Sanitation of manufacturing premises is important to ensure good hygiene of facilities, equipment, processes, and personnel. Cleaning and validation procedures should be established and records maintained.
2. Proper controls must be established to prevent mix-ups and cross-contamination during production. This includes separation of products, labeling, cleaning procedures, and qualified personnel.
3. Waste and scrap from manufacturing must be properly handled, collected, stored, and disposed of according to established guidelines. Hazardous and pharmaceutical wastes require special treatment and disposal.
This document discusses vendor qualification and product returns and recalls in the pharmaceutical industry. It provides definitions and guidelines for recall classification, initiation, and responsibilities of recalling firms. It also discusses vendor qualification categories and criteria for selection. The key points are that recall means removing violating products from the market, while return means sending unused products back. Firms must qualify vendors on various criteria like quality, delivery, and facilities to ensure consistent product quality.
CLEANING VALIDATION for M.pharm and industry personabhishek pandey
YOU CAN EASY WAY TO UNDERSTAND A PROCESS AND ANLYTICAL METHOD OF CLEANING VALIDATION
Cleaning validation is the methodology used to assure that a cleaning process removes residues of the active pharmaceutical ingredients of the product manufactured in a piece of equipment, the cleaning aids utilized in the cleaning process and the microbial attributes.[1] All residues are removed to predetermined levels to ensure the quality of the next product manufactured is not compromised by waste from the previous product and the quality of future products using the equipment, to prevent cross-contamination and as a GMP requirement.
The U.S. Food and Drug Administration (FDA) has strict regulation about the cleaning validation. For example, FDA requires firms to have written general procedures on how cleaning processes will be validated. Also, FDA expects the general validation procedures to address who is responsible for performing and approving the validation study, the acceptance criteria, and when revalidation will be required. FDA also require firms to conduct the validation studies in accordance with the protocols and to document the results of studies.The valuation of cleaning validation is also regulated strictly, which usually mainly covers the aspects of equipment design,cleaning process written, analytical methods and sampling. Each of these processes has their related strict rules and requirements. Regarding to the establishment of limits, FDA does not intend to set acceptance specifications or methods for determining whether a cleaning process is validated. But some limits that have been mentioned by industry include analytical detection levels such as 10 PPM, biological activity levels such as 1/1000 of the normal therapeutic dose and organoleptic levels.[2][3][4]
Cleaning Validation in the context of Active Pharmaceutical Ingredient manufacture may be defined as: "The process of providing documented evidence that the cleaning methods employed within a facility consistently controls potential carryover of product (including intermediates and impurities), cleaning agents and extraneous material into subsequent product to a level which is below predetermined levels".
Manufacturing operations and control must ensure identity, strength, safety, and purity of products. Facilities must be properly sanitized and cleaned to prevent contamination and mix-ups. During packaging, lines must be cleared properly and monitoring must ensure integrity of finished products. In-process and finished product testing must meet specifications before final product release. Strict controls over materials, personnel, equipment, and facilities help guarantee quality and prevent issues like cross contamination.
In this slide contains Introduction, levels of cleaning, mechanism, sampling method of cleaning validation.
Presented by: P. VENKATESH (Department of pharmaceutical analysis).RIPER, anantapur
The document outlines the standard operating procedure for sampling, testing, and releasing or rejecting finished products. It describes the steps taken by quality control personnel, including receiving sampling requests, collecting and labeling samples, distributing samples for analysis, testing samples according to procedures, reviewing results, and releasing or rejecting batches based on specifications. Key steps involve sampling from containers, analyzing samples in the chemical and instrument labs, approving results, and recording the final status of batches.
The document outlines the standard operating procedure for sampling, testing, and releasing or rejecting finished products. It describes the steps taken by quality control personnel including receiving sampling requests, collecting and labeling samples, distributing samples for analysis, testing samples according to procedures, reviewing results, and releasing or rejecting batches based on specifications. Key steps involve sampling from containers, analyzing samples in the chemical and instrument labs, approving results, and determining the batch's status.
The document outlines the standard operating procedure for sampling, testing, and releasing or rejecting finished products. It describes the steps taken by quality control personnel including receiving sampling requests, collecting and labeling samples, distributing samples for analysis, testing samples according to procedures, reviewing results, and issuing a certificate of analysis to determine if a batch is released for further processing or rejected. Additional tests may also be performed depending on customer or regulatory requirements.
This document outlines the process for sampling, testing, and releasing or rejecting packing materials. It describes how quality control receives notification of incoming materials and assigns a sampling executive to verify details and sample containers according to a sampling plan table. The executive records sampling observations and notifies others if issues arise. Samples are tested according to standard procedures and recorded, and status labels of approval or rejection are affixed to containers before the material receipt report and analysis certificate are sent to the warehouse. Primary packing materials undergo complete analysis for each lot while secondary materials have a reduced testing plan.
1) Sampling procedures in bottling facilities involve sampling both the water before bottling and the bottled water itself.
2) Proper sampling requires selecting trained personnel, appropriate sample containers, preservation and transportation equipment, and ensuring samples are representative of conditions at the time of sampling.
3) Documentation of sampling includes unique sample IDs, dates, locations, intended analyses, and other details to ensure sample integrity from collection through analysis.
Sampling and analysis methods should follow scientifically recognized principles and procedures. Laboratory methods for analysis should be developed and validated scientifically, and preference should be given to reliable, routine methods. Laboratories must ensure analytical competency for each method used and maintain appropriate documentation. A variety of sampling tools and procedures are described for different feed ingredients and products depending on their physical form. Sample reduction, storage, and retention are also discussed.
STANDARD OPERATING PROCEDURES FOR PARENTERAL DOSAGE FORM PREPARATIONAVIJIT BAKSHI
PRESENTATION CONTAINS THE INFORMATION ABOUT STANDARD OPERATING PROCEDURES FOR PARENTERAL DOSAGE FORM PREPARATION FOLLOWED BY PHARMACEUTICAL MANUFACTURING COMPANIES.
Pharmaceuticals Sampling plans and techniquesAshishVerma593
Sampling plans and techniques are used to select representative samples from pharmaceutical populations for testing purposes. There are three main WHO sampling formulae: n Plan uses the square root of the population plus one, p Plan uses 0.4 times the square root of the population, and r Plan uses 1.5 times the square root of the population. These formulae are used depending on factors like uniformity and source. Finished products and packaging materials should follow standards like ISO 2859 level II. The AQL provides guidelines on acceptable defect levels based on sample size and inspection level.
Drawal of samples, storage, disposal of narcotics drugs.pptimtiaz787855
1) The document outlines procedures for drawing samples, storing, and disposing of narcotics drugs that have been seized. It discusses drawing samples of the seized drugs in duplicate, packing and sealing the samples, preparing test memos, and dispatching samples within 72 hours to the laboratory for testing.
2) It also describes storing the remaining seized drugs in a dedicated godown, maintaining a godown register, and the roles and responsibilities of the godown in-charge. Pre-trial and post-trial disposal procedures are also summarized, including the formation of a drug disposal committee.
3) The key steps for pre-trial disposal outlined are obtaining a court order certifying inventories, photographs and samples drawn
Drugconfirm Advanced substance abuse urine screening device is available in multiple configurations 5-14 panel with k2,etg alcohol,fentanyl and more illicit drugs of abuse. Visit www.rapidexams.com today and save up to 15%.
Training for sample transportation for transportersDilanThennakoon
This document provides guidelines for proper sample transportation. It discusses maintaining proper temperature control between 2-8°C during transportation. The triple packaging system is recommended to prevent spillage. Issues with improper transportation can lead to inappropriate patient care decisions due to delayed or incorrect results. Sample retention times and storage conditions are also outlined to ensure sample integrity until analysis. Proper procedures must be followed to safely transport clinical samples from collection to the laboratory.
This slide is beneficial for the Indian Police dept while sampling NDPS drugs. Many police officers are unaware of how much amount can be taken for examination purposes and for reserve samples. So in this slide, all laws are given.
The document discusses quality assurance in haemostasis laboratory testing. It outlines the importance of accuracy and precision in test results. There are three main types of quality assurance: internal quality control, external quality control, and participation in proficiency testing programs. The document also describes pre-analytic, analytic, and post-analytic factors that can affect test results and outlines standard operating procedures to ensure quality at each stage of testing. Maintaining reliable test results requires strict control of all variables from specimen collection through analysis and reporting.
This document provides a guide to running quality control (QC) samples in a laboratory. It outlines the steps for receipt and storage of QC materials, including recommended temperature conditions. It describes safe handling practices and preparation steps for different types of controls, such as liquid ready-to-use, liquid frozen, and lyophilized controls. The guide also covers the application and interpretation of QC results to ensure test values fall within the expected ranges listed on the product insert. Following the procedures outlined helps ensure proper QC monitoring of analytical testing in the laboratory.
The document discusses proper sample management procedures for a laboratory. It emphasizes that sample quality directly impacts the accuracy of test results and patient care. Key aspects of sample management include detailed collection instructions, proper labeling, handling and transport of samples, criteria for rejecting unacceptable samples, and ensuring samples are collected according to testing requirements. Adhering to standardized sample management procedures helps produce reliable results and avoid errors.
The audit team consisted of the lead auditor and two other auditors, Jennifer and Bella. They found issues with material controls, component preparation, lyophilization, capping and sealing, and site QA. Specifically, there was no procedure for supplier audits, components were released prior to inspection, cleaning validation was lacking for the siliconization vessel, and investigations of failed batches took too long. Additionally, veterinary products were produced on approved product lines without proper media simulations between. The sterility test for one batch identified viruses and bacteria. For the close-out meeting, the lead auditor will give the report to site management.
GMP helps in providing quality standard product. Subpart - E is related to Control of Components and Drug product containers and closures. Subpart - F is related to Production and Process control.
Contoh protokol validasi metode analisis mikrobiologi #2Guide_Consulting
Disampaikan pada seminar validasi metode analisis mikrobiologi 19 sep 2013, Bogor
Untuk mendapat file nya silahkan kirimkan email beserta data (nama, perusahaan, alamat email, no telp) ke Guide Consulting | info@traininglaboratorium.com
The document discusses quality control procedures for a microbiology laboratory. It outlines monitoring, evaluating, and record keeping for equipment, reagents, media, and test procedures to ensure accurate and reproducible results. Reference strains are listed for quality control testing of Gram stains, culture media, antibiotic disks, and other reagents. Acceptance and rejection criteria are provided for specimens to ensure only suitable samples are tested.
FDA inspections ( how to survive an FDA inspection)shaik malangsha
This document provides guidance on how to prepare for and survive a FDA inspection of a clinical trial site. It discusses the different types of inspections, including routine inspections triggered by an application submission and for-cause inspections due to complaints. When receiving notice of an inspection, key steps are to obtain inspection details, notify relevant parties, and prepare documents and staff. During the inspection, escort the inspector, provide requested documents, answer questions honestly but do not speculate. The inspector will verify study conduct and documentation.
Stability studies are conducted to prove how the quality of a drug substance or product varies over time under different environmental conditions like temperature, humidity, and light. The purpose is to determine the shelf life and appropriate storage conditions. Key factors that can affect stability include active ingredient properties, interactions, manufacturing process, dosage form, container, and storage conditions during transport and handling. Studies are done under long term, accelerated, and intermediate conditions following protocols to collect data at various time points and interpret results to establish expiration dates.
FDA Inspections ( How to Survive an FDA Inspection)shaik malangsha
The document provides guidance on surviving an FDA inspection, including describing the types of inspections, how to prepare, what to expect during the inspection process, common findings, and next steps after the inspection. It details how to handle an announced inspection, including obtaining key details, notifying relevant parties, preparing documents and staff, and interacting with inspectors during the process. The document outlines the inspector's focus on compliance, informed consent, reporting, monitoring, and accuracy of source documents and reported data. It stresses responding professionally and addressing any deficiencies found.
FDA Inspections ( How to Survive an FDA Inspection).pptshaik malangsha
This document provides guidance on how to prepare for and survive a FDA inspection of a clinical trial site. It discusses the different types of inspections, including routine inspections triggered by an application submission and for-cause inspections due to complaints. When receiving notice of an inspection, key steps are to obtain inspection details, notify relevant parties, and prepare documents and staff. During the inspection, FDA inspectors will verify protocol adherence and delegation of duties. Answering questions honestly and avoiding speculation are important.
The document discusses Good Manufacturing Practices (GMP) guidelines according to ICH Q7A. It states that both GMP and cGMP aim to prevent bad quality products from entering the market. GMP applies to pharmaceutical and healthcare products, while cGMP refers specifically to FDA standards which require using the most up-to-date processes. Regulatory agencies that establish GMP standards are mentioned, along with ICH quality guidelines and principles such as quality management, personnel qualifications, facilities requirements, equipment cleaning, calibration, documentation, and batch records.
The document discusses Good Manufacturing Practices (GMP) guidelines according to ICH Q7A. It states that both GMP and cGMP aim to prevent bad quality products from entering the market. GMP applies to pharmaceutical and healthcare products, while cGMP refers to using the most up-to-date production processes and technologies to comply with regulations, as defined by the FDA. Regulatory agencies that establish GMP standards are mentioned, along with the objectives of GMP and specific guidelines covering quality management, personnel, facilities, equipment, documentation, and production records.
I am uploading this GMP presentation to make aware who are working in pharma and help to maintain high standards in products manufacturing .
GMP Vs cGMP: It is my understanding that , Ultimately GMP & cGMP both the aim is same, means to prevention of the product from bad quality entering the market to endover peoples's life.
GMP applies to pharmaceutical and healthcare products and help to maintain high standards in these products.
cGMP is to remind accepting countries that all guidelines must be followed with latest and current production processes i.e employ technologies and systems which are up-to-date in order to comply with the regulation.
FDA (Food and Drug Administration) included the word “current” to ensure that regulated firms use the most current Good Manufacturing Practices (I believe that some firms would actually use outdated versions of the GMP’s to manufacture regulated products.
(the FDA have made their standards immediately identifiable i.e cGMP; Other international bodies such as the ICH, WHO use the term GMP, as do Canada, Japan and the EMEA (European authority). In FDA view cGMP means following 21 CFR 210 and 211 and no other.)
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Muktapishti is a traditional Ayurvedic preparation made from Shoditha Mukta (Purified Pearl), is believed to help regulate thyroid function and reduce symptoms of hyperthyroidism due to its cooling and balancing properties. Clinical evidence on its efficacy remains limited, necessitating further research to validate its therapeutic benefits.
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Integrating Ayurveda into Parkinson’s Management: A Holistic Approach
Raw materials presentation
1. SAMPLING, TESTING AND
RELEASE / REJECTION OF
RAW MATERIALS
Presented by
Malangsha
shkrahul42@gmail.com
1
SAMPLING, TESTING AND
RELEASE / REJECTION OF
RAW MATERIALS
Presented by
Malangsha
shkrahul42@gmail.com
2. Quality control shall receive "Material Received Report (MRR) from
Warehouse as an intimation for raw material sampling.
Upon receipt, sampling Executive shall verify the details on the
MRR and supplier COA.
Sampling Executive shall enter the details in the Raw Material
Inward Record as per the MRR and assigns an Analytical Reference
Number as per SOP.
Sampling I analysis priority shall be decided upon the requirement of
material and production plan, in case of multi MRR receipt.
Executive-QC shall prepare the required number of labels (i.e.,
"Sample for analysis" and"Sampled") as defined in the below sampling
plan.
2
Quality control shall receive "Material Received Report (MRR) from
Warehouse as an intimation for raw material sampling.
Upon receipt, sampling Executive shall verify the details on the
MRR and supplier COA.
Sampling Executive shall enter the details in the Raw Material
Inward Record as per the MRR and assigns an Analytical Reference
Number as per SOP.
Sampling I analysis priority shall be decided upon the requirement of
material and production plan, in case of multi MRR receipt.
Executive-QC shall prepare the required number of labels (i.e.,
"Sample for analysis" and"Sampled") as defined in the below sampling
plan.
3. Sampling plan
1 to 5 All
6 to 10 6
11 to 20 7
21 to 56 8
More than 56 --./n+ 1*
If the decimal in --./n value is less than 5, it shall be rounded to the
lowest value, if it is more than or equal to 5, it shall be rounded to
the highest value.
3
Sampling plan
1 to 5 All
6 to 10 6
11 to 20 7
21 to 56 8
More than 56 --./n+ 1*
If the decimal in --./n value is less than 5, it shall be rounded to the
lowest value, if it is more than or equal to 5, it shall be rounded to
the highest value.
4. Note: For the new vendor first three consignments of starting
raw materials, composite sample shall be prepared from all
the containers (100% sampling), irrespective of the sampling
plan.
Executive-QC shall carry self-sealed polyethylene bags,
glass bottles, cleaned sampling devices (such as SS Scoop,
thief sampler/glass sampler), prepared labels and sampling
record to proceed for sampling.
Sampling Executive shall verify the physical condition,
consignment details and "Under Test" label of the containers
against MRR.
In case of discrepancy the same shall be recorded and
immediately informed to warehouse in charge for rectification.
4
Note: For the new vendor first three consignments of starting
raw materials, composite sample shall be prepared from all
the containers (100% sampling), irrespective of the sampling
plan.
Executive-QC shall carry self-sealed polyethylene bags,
glass bottles, cleaned sampling devices (such as SS Scoop,
thief sampler/glass sampler), prepared labels and sampling
record to proceed for sampling.
Sampling Executive shall verify the physical condition,
consignment details and "Under Test" label of the containers
against MRR.
In case of discrepancy the same shall be recorded and
immediately informed to warehouse in charge for rectification.
5. Executive-QC shall randomly select the containers for
sampling and instruct the warehouse personnel to shift the same
containers to sampling booth.
Executive-QC shall wear the safety devices and
proceeds for sampling of selected containers one by one in
the sampling booth.
Sampling Executive shall check the physical appearance of
the material and mix the contents thoroughly within the container
by sampling devices (SS scoops/Thief sampler for solids or glass
sampler for liquids) and collects the sample in self sealed bags
(for solids) and glass bottles (for liquids). 5
Executive-QC shall randomly select the containers for
sampling and instruct the warehouse personnel to shift the same
containers to sampling booth.
Executive-QC shall wear the safety devices and
proceeds for sampling of selected containers one by one in
the sampling booth.
Sampling Executive shall check the physical appearance of
the material and mix the contents thoroughly within the container
by sampling devices (SS scoops/Thief sampler for solids or glass
sampler for liquids) and collects the sample in self sealed bags
(for solids) and glass bottles (for liquids).
6. Post sampling, container shall be sealed or closed immediately
and "Sampled" labels shall be affix on the containers adjacent
to under test Labels.
Sampling Executive shall take equal quantity from each
container and collect composite sample .
If the physical appearance of the material is varying from
container to container and specification as well, sampling
activity shall be discontinued and informed to Head-QC.
In such case Head-QC along with QA representative
shall approach ware house and verifies the physical
appearance of the material.
6
Post sampling, container shall be sealed or closed immediately
and "Sampled" labels shall be affix on the containers adjacent
to under test Labels.
Sampling Executive shall take equal quantity from each
container and collect composite sample .
If the physical appearance of the material is varying from
container to container and specification as well, sampling
activity shall be discontinued and informed to Head-QC.
In such case Head-QC along with QA representative
shall approach ware house and verifies the physical
appearance of the material.
7. If the material is confirmed failing in physical appearance,
consignment shall be rejected without OOS investigation.
If the physical appearance of the material in all the containers
is similar and complying, all the samples shall be collected
compositely.
All observations of sampling shall be recorded in "Raw
material sampling record"
Sampled containers shall be shifted to their original place
immediately.
Details of sampling shall be entered into the sampling booth
usage and cleaning record of warehouse. 7
If the material is confirmed failing in physical appearance,
consignment shall be rejected without OOS investigation.
If the physical appearance of the material in all the containers
is similar and complying, all the samples shall be collected
compositely.
All observations of sampling shall be recorded in "Raw
material sampling record"
Sampled containers shall be shifted to their original place
immediately.
Details of sampling shall be entered into the sampling booth
usage and cleaning record of warehouse.
8. Collected composite sample shall be brought to QC and
divided into 3 parts in sample distribution area.
One part shall be preserved as retention sample (for starting
raw material only) and other two parts shall be used for
complete analysis (at wet and Instrumentation labs)
The QC Analyst shall test the samples as per respective
standard test procedures.
If the sample meets the individual specification, material
shall be approved and retention sample shall be logged.
Incase sample does not meet the specification OOS shall be
raised and investigation shall be carried out.
25.0 Based on the investigation status of the material shall be
8
Collected composite sample shall be brought to QC and
divided into 3 parts in sample distribution area.
One part shall be preserved as retention sample (for starting
raw material only) and other two parts shall be used for
complete analysis (at wet and Instrumentation labs)
The QC Analyst shall test the samples as per respective
standard test procedures.
If the sample meets the individual specification, material
shall be approved and retention sample shall be logged.
Incase sample does not meet the specification OOS shall be
raised and investigation shall be carried out.
25.0 Based on the investigation status of the material shall be
9. Liquid raw materials (in tankers) sampling sequence:
Sampling Executive shall take prepared sample labels, Glass
bottles, sampling checklist, Glass sampler and proceeds for
sampling.
Sampling Executive shall verify the compartment wise Seal
Naive intact and "Under test labels" before sampling.
Sampling Executive shall break the compartment seals and
open the lids one by one.
Sampling Executive shall rinse the sampler thrice with the
material and collect the samples from the top of each compartment
compositely into a glass bottle, if the physical appearance is
similar in all compartments.
9
Liquid raw materials (in tankers) sampling sequence:
Sampling Executive shall take prepared sample labels, Glass
bottles, sampling checklist, Glass sampler and proceeds for
sampling.
Sampling Executive shall verify the compartment wise Seal
Naive intact and "Under test labels" before sampling.
Sampling Executive shall break the compartment seals and
open the lids one by one.
Sampling Executive shall rinse the sampler thrice with the
material and collect the samples from the top of each compartment
compositely into a glass bottle, if the physical appearance is
similar in all compartments.
10. Sampling Executive shall open the bottom valves and drain
about 5 to 10 liters of the liquid into buckets. Then samples shall
be collected from bottom of each compartment compositely into a
glass bottle, if the physical appearance is similar in all
compartments.
Post sampling, compartments shall be sealed or closed
immediately and "Sampled" labels shall be affix on the tanker
adjacent to under test Label.
If the physical appearance of the material is varying from
container to container and specification as well, sampling activity
shall be discontinued and informed to Head-QC.
10
Sampling Executive shall open the bottom valves and drain
about 5 to 10 liters of the liquid into buckets. Then samples shall
be collected from bottom of each compartment compositely into a
glass bottle, if the physical appearance is similar in all
compartments.
Post sampling, compartments shall be sealed or closed
immediately and "Sampled" labels shall be affix on the tanker
adjacent to under test Label.
If the physical appearance of the material is varying from
container to container and specification as well, sampling activity
shall be discontinued and informed to Head-QC.
11. ln such case Head-QC along with QA representative shall
personally verify the physical appearance of the material. If the
material is confirmed failing in physical appearance, consignment
shall be rejected without OOS investigation.
If the physical appearance of the material in top / bottom portion
is similar and complying, a composite sample shall be prepared and
brought to QC for analysis.
The QC Analyst shall test the samples as per respective standard
test procedures.
If the sample meets the individual specification, material shall be
approved and tanker material shall be unloaded into bulk storage
tank.
11
ln such case Head-QC along with QA representative shall
personally verify the physical appearance of the material. If the
material is confirmed failing in physical appearance, consignment
shall be rejected without OOS investigation.
If the physical appearance of the material in top / bottom portion
is similar and complying, a composite sample shall be prepared and
brought to QC for analysis.
The QC Analyst shall test the samples as per respective standard
test procedures.
If the sample meets the individual specification, material shall be
approved and tanker material shall be unloaded into bulk storage
tank.
12. Quantity unloaded shall be intimated by warehouse and the
same shall be recorded in the raw material inward! sampling check
list and protocol.
Warehouse shall request a fresh A.R.No. for the composite material
of storage tank once unloading is completed.
Incase sample does not meet the specification OOS shall be
raised and investigation shall be carried out.
Based on the investigation, status of the material shall be decided
accordingly.
Analyst shall perform the analysis as per the product STP and
records the raw data in the. "Raw material test protocol". 12
Quantity unloaded shall be intimated by warehouse and the
same shall be recorded in the raw material inward! sampling check
list and protocol.
Warehouse shall request a fresh A.R.No. for the composite material
of storage tank once unloading is completed.
Incase sample does not meet the specification OOS shall be
raised and investigation shall be carried out.
Based on the investigation, status of the material shall be decided
accordingly.
Analyst shall perform the analysis as per the product STP and
records the raw data in the. "Raw material test protocol".
13. Analyst shall record instrument usage details in respective
equipment logbooks.
Analyst shall attach the calculations / observations /
chromatograms with the test protocols.
Test wise results shall be compiled in the certificate of analysis
and forwarded to reviewer (section head) for cross verification.
Section head shall review the raw data thoroughly and upon
execution further forwards the report to Head-QC/Deputy for
approval.
In-charge - QC I deputy shall verify the data randomly and
approves the document for release. 13
Analyst shall record instrument usage details in respective
equipment logbooks.
Analyst shall attach the calculations / observations /
chromatograms with the test protocols.
Test wise results shall be compiled in the certificate of analysis
and forwarded to reviewer (section head) for cross verification.
Section head shall review the raw data thoroughly and upon
execution further forwards the report to Head-QC/Deputy for
approval.
In-charge - QC I deputy shall verify the data randomly and
approves the document for release.
14. Status label (Approved/Rejected labels) labels shall be prepared
and pasted on the under test labels of the containers.
MRR shall be sent to warehouse with status details along with
certificate of analysis.
In the case of failure in quality parameters, OOS (Out of
specification) shall be initiated for raw materials.
Further thorough investigation shall be carried out with document
evidence for OOS materials.
Based on the investigation recommendation, status of the material
shall be concluded.
The final status of the material shall be recorded in the raw
material inward registers along with date of release.
14
Status label (Approved/Rejected labels) labels shall be prepared
and pasted on the under test labels of the containers.
MRR shall be sent to warehouse with status details along with
certificate of analysis.
In the case of failure in quality parameters, OOS (Out of
specification) shall be initiated for raw materials.
Further thorough investigation shall be carried out with document
evidence for OOS materials.
Based on the investigation recommendation, status of the material
shall be concluded.
The final status of the material shall be recorded in the raw
material inward registers along with date of release.
15. Gases, Hazardous and Toxic raw materials:
Upon receipt of Gas cylinders/Tankers, Hazardous, Toxic raw
materials sampling Executive shall verify the details on the MRR
and supplier/manufacturer COA.
Sampling Executive shall enter the details in the Raw Material
Inward register as per the MRR and assigns an Analytical Reference
Number.
Sampling Executive shall approach the consignments and visual
verification shall be done.
15
Gases, Hazardous and Toxic raw materials:
Upon receipt of Gas cylinders/Tankers, Hazardous, Toxic raw
materials sampling Executive shall verify the details on the MRR
and supplier/manufacturer COA.
Sampling Executive shall enter the details in the Raw Material
Inward register as per the MRR and assigns an Analytical Reference
Number.
Sampling Executive shall approach the consignments and visual
verification shall be done.
16. Sampling shall not be performed for such raw materials and
released as per the vendor certificate of analysis.
In the case of captive consumption material transfers, earlier
tested certificate of analysis shall be considered for release.
16