Risk assessment for computer system validationBangaluru
A risk assessment is a process to identify potential hazards and analyze what could happen if a hazard occurs.
Computer system validation (sometimes called computer validation or CSV) is the process of documenting that a computer system meets a set of defined system requirements.
Self-inspection should be carried out in order to verify compliance by the enterprise with the requirements of these Rules and suggest the necessary corrective actions.
quality audit is essential for every organization . It discover the draw backs and then by improving this we can grow .It provide high degree of confidence.
A quality management system (QMS) is a set of policies, processes and procedures required for planning and execution (production/development/service) in the core business area of an organization (i.e., areas that can impact the organization’s ability to meet customer requirements). ISO 9001 is an example of a Quality Management System.
TQM is the integration of all functions and processes within an organization to achieve continuous improvement of the quality of goods and services.
The goal is customer satisfaction.
Six Sigma (Quality Management System)
Six Sigma seeks to improve the quality of process outputs by identifying and removing the causes of defects.
Six sigma process is one in which 99.9999966% of the products manufactured are statistically expected to be free of defects.
Six sigma is a very clever way of branding and packaging many aspects of TOTAL QUALITY MANAGEMENT.
Quality audit is defined as a systematic and independent examination to determine whether activities and related results comply with planned arrangements and whether these arrangements are implemented effectively and are suitable to achieve objectives Quality audit means a systematic examination of a quality system
Quality audits are typically performed at defined intervals
.Definition
Objectives
Difference between Quality audit and Periodic evaluation
Self inspection
Types of Quality Audit
Role OF GMP Audit in QA and QC programmes
Elements of a Systemic Audit program
Dr. V. S. Kashikar
Instant GMP Compliance Series - Improving DocumentationInstantGMP™
The FDA enforces the Dietary Supplement Health and Education Act (DSHEA) law by inspecting dietary supplement manufacturers, packagers, labelers and holders for Current Good Manufacturing Practices (cGMPs) compliance. One of the main issues they found was the lack of proper documentation. This presentation provides an overview of the documentation that is needed for cGMP compliance.
Risk assessment for computer system validationBangaluru
A risk assessment is a process to identify potential hazards and analyze what could happen if a hazard occurs.
Computer system validation (sometimes called computer validation or CSV) is the process of documenting that a computer system meets a set of defined system requirements.
Self-inspection should be carried out in order to verify compliance by the enterprise with the requirements of these Rules and suggest the necessary corrective actions.
quality audit is essential for every organization . It discover the draw backs and then by improving this we can grow .It provide high degree of confidence.
A quality management system (QMS) is a set of policies, processes and procedures required for planning and execution (production/development/service) in the core business area of an organization (i.e., areas that can impact the organization’s ability to meet customer requirements). ISO 9001 is an example of a Quality Management System.
TQM is the integration of all functions and processes within an organization to achieve continuous improvement of the quality of goods and services.
The goal is customer satisfaction.
Six Sigma (Quality Management System)
Six Sigma seeks to improve the quality of process outputs by identifying and removing the causes of defects.
Six sigma process is one in which 99.9999966% of the products manufactured are statistically expected to be free of defects.
Six sigma is a very clever way of branding and packaging many aspects of TOTAL QUALITY MANAGEMENT.
Quality audit is defined as a systematic and independent examination to determine whether activities and related results comply with planned arrangements and whether these arrangements are implemented effectively and are suitable to achieve objectives Quality audit means a systematic examination of a quality system
Quality audits are typically performed at defined intervals
.Definition
Objectives
Difference between Quality audit and Periodic evaluation
Self inspection
Types of Quality Audit
Role OF GMP Audit in QA and QC programmes
Elements of a Systemic Audit program
Dr. V. S. Kashikar
Instant GMP Compliance Series - Improving DocumentationInstantGMP™
The FDA enforces the Dietary Supplement Health and Education Act (DSHEA) law by inspecting dietary supplement manufacturers, packagers, labelers and holders for Current Good Manufacturing Practices (cGMPs) compliance. One of the main issues they found was the lack of proper documentation. This presentation provides an overview of the documentation that is needed for cGMP compliance.
In today’s complex global supply chain, proper supplier qualification is essential for avoiding supply chain failures and maintaining traceability of products.
There have been numerous public health crises in various industries regulated by the US Food and Drug Administration (FDA) related to contamination or adulteration of material along the supply chain.
Under Food Safety modernization Act (FSMA) Food and Drug Administration (FDA) issued final rule for Foreign Supplier Verification Programs (FSVP) on November 13, 2015
Safety Audit can be defined as verifying the existence and implementation of elements of occupational safety and health system and for verifying the system’s ability to achieve defined safety objectives.
This presentation will give you an overview of Audit, Safety Audit, Audit Process, Auditor attributes. It also discusses about the different reference standards in India related to safety audit and will give you some take home points.
Globalization has made it easier than ever to ignore where our clothes come from. The fashion industry has complex connections to many other fields, including manufacturing, advertising, production of raw materials, transportation and retailing. Begin to educate consumers about the importance of APPAREL STANDARDS.
This presentation is the first in a series of monthly Social Media Training titled Third Tech Tuesday. This month's training is on 10 Uses of Facebook for Business. The presentation is packed with resources.
InstantGMP Compliance Series - Improving Batch Production RecordsInstantGMP™
Batch record violations were frequently cited during FDA inspections of dietary supplement manufacturers. This presentation provides some guidance on what is needed for batch records to be in compliance with GMPs.
InstantGMP Compliance Series - Managing Deviations for Improved ComplianceInstantGMP™
Any time a deviation is made from the process in the batch production record, it has to be recorded, investigated and disposition. This presentation provides details on how this is done.
QA: It is the sum total of the organized arrangements with the objective of ensuring that products will be of the quality required for their intended.
GMP: Part of QA which ensures that products are consistently produced & controlled to the quality standards appropriate to their use.
GMP is an integral part of QA.
InstantGMP Compliance Series - Improving SpecificationsInstantGMP™
The FDA requires specifications for identity, strength, purity and composition for dietary supplement products. This presentation explains how to meet these GMP requirements.
InstantGMP Compliance Series - Improving Quality through In-Process ControlInstantGMP™
In-Process controls are needed at each step of a manufacturing procedure where the control of a critical process can affect the quality of the final product. This presentation explains how to set and use in-process controls.
Instant GMP Compliance Series -Better Compliance through Master Manufacturing...InstantGMP™
FDA inspections are increasing every year and they have published the results on their website. 50% of dietary supplement manufacturers are not in GMP compliance and 1 in 4 dietary supplement companies have received a warning letter which could result in a significant enforcement action such as halting production and distribution. Many of these producers received citation because they were not using Master Manufacturing Records.
Moving From Paper-Based Systems to Electronic Batch Records - InstantGMP™InstantGMP™
Technology is constantly evolving around us, and yet many manufacturers continue using paper-based systems to manage and record their activities while manufacturing. In recent times, many of these manufacturers, especially in pharmaceuticals and biotech, are making the move to a Manufacturing Execution System (MES) and Electronic Batch Records (EBR).
InstantGMP MD is the latest version of InstantGMP's good manufacturing practices software. MD brings manufacturers of medical devices into cGMP compliance by coming fully validated and compliant with Part 820.
Formulation Development of Poorly Soluble DrugsInstantGMP™
Poorly soluble drugs are the nemesis of formulation development scientists. Bruce Rehlaender the big issues and points out some approaches for dealing with these drugs and improving their bioavailability.
InstantGMP Compliance Series - Facility DesignInstantGMP™
The design of facilities used in the manufacturing of dietary supplements must meet strict requirements for preventing mix-ups and cross contamination. This presentation describes how this can be done.
InstantGMP Compliance Series - EquipmentInstantGMP™
Equipment used in producing dietary supplements fall under Good Manufacturing Practices. This presentation offers guidance on how to keep equipment in compliance.
Instant GMP Compliance Series for Dietary Supplements – Cost of ComplianceInstantGMP™
This presentation is one in a series of presentations that focus on good manufacturing practices and cGMP compliance for dietary supplements manufacturing. It’s brought to you by the quality and manufacturing experts at InstantGMP in the hope that it will help you avoid any cGMP compliance issues in your shop.
Instant GMP Compliance Series for Dietary Supplements – IntroductionInstantGMP™
Since 2010, the FDA has stepped up their inspections of dietary supplement manufacturers. At least 1 in 4 of those companies inspected received a Warning Letter to improve cGMP compliance or suffer regulatory action. This prompted us to prepare a series of presentations that will focus on good manufacturing practices and cGMP compliance for dietary supplements manufacturing. It’s brought to you by the quality and manufacturing experts at InstantGMP in the hope that it will help you avoid any cGMP compliance issues in your shop.
Any company involved in the dietary supplement business has to establish and to follow GMPs to ensure that packaging and labeling is done as specified in the master manufacturing record and to ensure the quality of the product that reaches the market. The presentation provides an overview of these requirements.
GMP Manufacturing for Worldwide Clinical Trials InstantGMP™
This presentation describes the complex process of manufacturing clinical trial materials using examples from the InstantGMP manufacturing execution system. InstantGMP is an electronic batch record system for small pharmaceutical operations and is ideal for manufacturing CTM or tracking inventory worldwide.
Pharmaceutical manufacturing has become a significant industry in India. It has been estimated that has the third largest pharmaceutical industry by volume We will examine how well they comply with Good Manufacturing Practices (GMP).
Specifications for GMP Dietary SupplementsInstantGMP™
Every manufacturer or distributor of dietary supplements has to be in compliance with Good Manufacturing Practices (GMP) requirements. GMP compliance for dietary supplements requires that products must meet specifications for identity, purity, strength, and composition and limits on contaminants. Also specifications are necessary to prevent adulteration as a result of what the manufacturer may do or fail to do in its manufacturing operation.
2. Problems - Qualifying Vendors
• FDA issued Warning Letters for GMP violations
of Dietary Supplement Health and Education Act
• Failure to adequately identify incoming dietary
ingredients
• Not establishing reliability of suppliers COA
• Not validating testing done by supplier
Electronic cGMP Manufacturing Execution System
3. Why Qualifying Vendors is Important
• Essential to show materials come from approved
vendors
• Reduces amount of final product testing needed
during or after production
• Reduces risk of final product being contaminated
or adulterated
Electronic cGMP Manufacturing Execution System
4. How to Improve
• Establish a Vendor Verification program
• Program should include:
– Audits of suppliers and vendors
– Confirming the test results of certificates of analysis
– Re-qualifying the vendor at periodic intervals
• Check that COAs include specifications for
identity, description, limits on contaminants,
results, strength, and tolerances
Electronic cGMP Manufacturing Execution System
5. DSHEA Requirements
• Conduct at least one test to verify identify of
each in-coming dietary ingredient
• COAs for other components are OK if:
– Test results are confirmed
– COA contains test, methods, acceptance limits and
results
– There is documentation on how supplier was qualified
– Periodic requalification is conducted
– Quality reviews and approves supplier
Electronic cGMP Manufacturing Execution System
6. Quality Surveys and Audits
• GMP Quality Survey
– Used to pre-qualify a vendor before deciding on a
more formal audit
– An example can be found at
www.instantgmp.com/Quality-Assurance-Templates
• On-Site Audit
– Conducted by a Quality professional
– Defines the authorized services or product
Electronic cGMP Manufacturing Execution System
7. Vendor Verification Program
• Qualification of all suppliers including
components, ingredients and labels
• Periodic audits and re-qualifying of vendors
• Confirmation of vendor's test results and COAs
• Reviews of specifications, procedures, and lab
controls
• Regular review of vendor’s documentation
Electronic cGMP Manufacturing Execution System
8. Audit Plan
• Agenda – list of areas and items to be reviewed
• Documents Requested prior to Audit
• Organizational structure
• Facility inspection
• Quality systems review
• Documentation Control and Record Keeping
• Training/ Personnel
Electronic cGMP Manufacturing Execution System
9. Audit Plan - Manufacturing
• Calibration procedures and documentation
• Procurement and Materials
• Processing and In-process inspection
• Final inspection and testing
• Distribution
• QC Laboratory
• Example at www.instantgmp.com/Quality-
Assurance-Templates.
Electronic cGMP Manufacturing Execution System
10. InstantGMP™
Find more videos on GMP
Manufacturing in the Resource
Center at
www.instantgmp.com
Editor's Notes
The staff at InstantGMP prepared the GMP for Dietary Supplements Compliance Series of presentations to focus on good manufacturing practices and GMP compliance for dietary supplements manufacturing. These are brought to you by our quality and manufacturing experts in the hope that it will help you avoid any GMP compliance issues in your shop. This presentation will address the qualification of suppliers and vendors.
The FDA issued Warning Letters for GMP violations of Dietary Supplement Health and Education Act that with citations concerning supplier and vendor qualification and certification. They issued one to a dietary supplement manufacture when found the firm had failed to provide sufficient assurance that products received from a supplier were adequately identified and consistent with their purchase order. Another firm failed to qualify suppliers of components other than dietary ingredients. They did not establish the reliability of the suppliers’ COA through confirmation of the results of the suppliers’ tests or examinations. A third firm did not establish the reliability of the supplier’s COA for raw materials tests such as pH, Water-soluble substances, Residue on Ignition and Assay.
An effective vendor qualification program is essential to ensure that material and components are procured from and provided by vendors that have been approved by a Quality Assurance representative. A well functioning vendor qualification program can significantly reduce the amount of testing that has to be done on in-coming materials. It also reduces the risk of a final product become contaminated or adulterated. The FDA is conducting ever more inspections of dietary supplement manufacturers and packagers and they are expecting a higher compliance rate in the future.
The first step is to establish a Vendor Verification program. This program should include: 1) Audits of suppliers and vendors, 2) Confirming the test results of certificates of analysis and 3) Re-qualifying the vendor at periodic intervals Check that COAs from vendors include specifications for identity, description, limits on contaminants, results, strength, and tolerances.
The Final Rule of the Dietary Supplement Health and Education Act requires that a manufacture of dietary supplements conducts at least one appropriate test or examination to verify the identity of each dietary ingredient that will be used in the manufacture of the dietary supplement. A firm may use certificates of analysis from supplier of a components (but not dietary ingredients), if certain criteria are met : (1) The firm first qualifies the supplier by establishing the reliability of the supplier's certificate of analysis through confirmation of the results of the supplier's tests or examinations; (2) the certificate of analysis includes a description of the test or examination method(s) used, limits of the test or examinations, and actual results of the tests or examinations; (3) the firm maintains documentation of how it qualified the supplier; (4) the firm periodically reconfirms the supplier's certificate of analysis; and (5) the firm's quality control personnel review and approve the documentation setting forth the basis for qualification (and requalification) of any supplier.
A GMP Quality Survey can be used to pre-qualify a potential vendor before conducting a more formal audit. An example can be found in the InstantGMP Resource Center at http://www.instantgmp.com/Quality-Assurance-Templates. The quality assessment, whether a survey or on-site audit must be conducted by a Quality professional. The assessment must define the service or product the vendor is authorized to supply. The assessment must be approved by a Quality representative.
A Vendor Verification Program should consist of: Qualification of all suppliers including components, ingredients, labels, etc. audits and periodic re-qualification of vendors, Confirmation of vendor's test results and certificates of analysis Reviews of specifications, procedures, and lab controls Regular review of vendor’s documentation
A typical audit plan for a qualifying a dietary ingredient vendor or other component supplier will include the following: Agenda – make a list items you expect to review during the audit - for example, Current Organizational Charts, previous FDA/Regulatory Inspections, EIRs, FDA-483’s, Warning Letters etc. Documents Requested prior to Audit - List any documents you would like the audit site to send prior to the audit. Organizational structure - clearly define the line of authority and responsibility for quality. Facilities – inspect all areas of the facility to determine if they are well designed, organized and clean. Equipment must be maintained and environmental controls employed. Quality Systems - records of all inspections, evaluations and validations performed should be analyzed. Documentation Control and Record Keeping - evaluate how control of documentation is done. Training/ Personnel - assess adherence to corporate policies and GMPs regarding cleanliness, garments and personal habits.
The audit plan for assessing manufacturing will include an inspection of: Calibration procedures and documentation – check for Periodic inspection and calibration of tools, gages, testers, and equipment. Procurement and Materials – assure suppliers have been monitored and incoming materials requirements have been met Processing and In-process inspections – assure that quality characteristics have been evaluated and verified during the production process. Final inspection and testing – determine that these ensure the acceptability of the product. Evaluate if rejections have been investigated thoroughly and corrective actions implemented. Distribution – determine that traceability of the material/product was maintained throughout the distribution chain. QC Laboratory – Check the lab areas for acceptability and procedures for adequate validation and review. An example of an Audit Checklist can be found in the InstantGMP Resource Center at http://www.instantgmp.com/Quality-Assurance-Templates.
Thank you for viewing our series on GMPs. You can find more videos and articles on GMP manufacturing in our Resource Center at www.InstantGMP.com.