This document provides an overview of material management in the pharmaceutical industry. It discusses the various types of materials that must be managed, including raw materials, packaging materials, intermediates, finished products, rejected materials, and more. For each material type, it outlines the processes for purchasing, receiving, inspecting, storing, sampling, identifying, and dispatching the materials. Maintaining proper documentation and storage conditions at each stage is emphasized. The overall goal of pharmaceutical material management is to ensure the right quality and quantity of materials are obtained and handled correctly to enable the production of quality finished products.
A short presentation about good ware house practicing and GMP requiremnts regarding this .And other pros and cons related to it.Hope it would be helpful.
Analysis of Raw materials…..
This topic comes under Quality Control and Quality Assurance…….
This is useful for M.Pharm (Pharmaceutical Quality Assurance) Students who studying in Fist year sem I......
This Presentation Contain following...
#Definition
#Purchase Specification
#GMP & WHO guidelines for handling of raw materials
#Control on Raw Materials
#Sampling of Raw Materials
#Raw Materials Testing
Thanks for Help and Guidance of Dr. F. A. Tamboli Sir and Dr.Mrs. N.M.Bhatia Madam
A short presentation about good ware house practicing and GMP requiremnts regarding this .And other pros and cons related to it.Hope it would be helpful.
Analysis of Raw materials…..
This topic comes under Quality Control and Quality Assurance…….
This is useful for M.Pharm (Pharmaceutical Quality Assurance) Students who studying in Fist year sem I......
This Presentation Contain following...
#Definition
#Purchase Specification
#GMP & WHO guidelines for handling of raw materials
#Control on Raw Materials
#Sampling of Raw Materials
#Raw Materials Testing
Thanks for Help and Guidance of Dr. F. A. Tamboli Sir and Dr.Mrs. N.M.Bhatia Madam
A vendor audit is a vehicle used by pharmaceutical companies, and other large companies as well, to inspect and evaluate a vendor’s quality management system, as well as its practices, products, and documentation.
The need to conduct vendor audits stems from a higher need for quality control in an industry that needs to be more regulated than any other industry in the world.
Reason why organizations use audits is to reduce cost and improve quality control
The objective of vendor audit is to develop an audit function comprising of qualified resources to effectively perform compliance audits to ensure that the contracts are being executed in accordance with the intent and address the net benefit to include cost recoveries, process improvement savings, fraud improvement and identification of hidden risks.
In order to reduce the cost pharmaceutical companies have increasingly become dependent on their supplier/ out sourcing partners for customer success. Though it has drastically reduced the production cost for companies, there is a heightened supplier risk and lack of visibility into supplier processes.
To gain an insight into supplier process and eliminate the risks, FDA encourages companies to conduct GMP supplier audit at the manufacturing premises of the supplier.
According to GMP code, it is sole responsibility of pharmaceutical industry to ensure that the suppliers manufacturing process, analytical tests and examinations are carried out reliably by the supplier and are in compliances with the applicable standards and regulations.
After the audit supplier must provide an appropriate corrective action plan with measures that that will be implemented by the supplier within a defined time frame to the manufacturer.
Process Validation is Key important factor for the Pharmaceutical Industry to maintain Consistent Quality in product which claimed by the manufacturer.
When designing a pharmaceutical manufacturing facility, the ways in which materials are moved from one stage of production to another should be considered from the very beginning. so the drug industry location and design considered crucial and should be according to GMP standards.
Manufacturing Control Systems. J R Controls provides control systems for the manufacturing industry. A typical control system will monitor the progress of parts through the manufacturing and finishing process.
Ipqc tests for sterile formulations are as follows :
Leakage Test
Clarity Test
pH
Particulate Matter Injection
SterilityTest
Pyrogen Test
Content Uniformity & Weight
Volume Filled
The tests For Sterile products are as per IP, BP & USP
A vendor audit is a vehicle used by pharmaceutical companies, and other large companies as well, to inspect and evaluate a vendor’s quality management system, as well as its practices, products, and documentation.
The need to conduct vendor audits stems from a higher need for quality control in an industry that needs to be more regulated than any other industry in the world.
Reason why organizations use audits is to reduce cost and improve quality control
The objective of vendor audit is to develop an audit function comprising of qualified resources to effectively perform compliance audits to ensure that the contracts are being executed in accordance with the intent and address the net benefit to include cost recoveries, process improvement savings, fraud improvement and identification of hidden risks.
In order to reduce the cost pharmaceutical companies have increasingly become dependent on their supplier/ out sourcing partners for customer success. Though it has drastically reduced the production cost for companies, there is a heightened supplier risk and lack of visibility into supplier processes.
To gain an insight into supplier process and eliminate the risks, FDA encourages companies to conduct GMP supplier audit at the manufacturing premises of the supplier.
According to GMP code, it is sole responsibility of pharmaceutical industry to ensure that the suppliers manufacturing process, analytical tests and examinations are carried out reliably by the supplier and are in compliances with the applicable standards and regulations.
After the audit supplier must provide an appropriate corrective action plan with measures that that will be implemented by the supplier within a defined time frame to the manufacturer.
Process Validation is Key important factor for the Pharmaceutical Industry to maintain Consistent Quality in product which claimed by the manufacturer.
When designing a pharmaceutical manufacturing facility, the ways in which materials are moved from one stage of production to another should be considered from the very beginning. so the drug industry location and design considered crucial and should be according to GMP standards.
Manufacturing Control Systems. J R Controls provides control systems for the manufacturing industry. A typical control system will monitor the progress of parts through the manufacturing and finishing process.
Ipqc tests for sterile formulations are as follows :
Leakage Test
Clarity Test
pH
Particulate Matter Injection
SterilityTest
Pyrogen Test
Content Uniformity & Weight
Volume Filled
The tests For Sterile products are as per IP, BP & USP
• Material Requirement Planning and Capacity Requirement
• Thought put Time
• Order Cycle Time
• Customer Satisfaction
• Quality
• Specifying Materials
• Maintenance Repair and Operating (MRO) Supplies
• Tooling
material management ppt describe the what is material management, aim of material management, objective of material management and function of material management
My project Hospital Management System include registration of patients,storing their detail into the system and also computerized .My software has the facility to give a unique id for every patient and store the detail of every patient and doctor automatically. User can search availability of a doctor and the details of a patient using the id.
ANALYSIS OF RAW MATERIALS, FINISHED PRODUCTS, PACKAGING MATERIALS, IPQC, CPCS...Khadeeja6
RAW MATERIALS
It is basically the chemical ingredients of a process. starting material, in production of final product.
FINISHED PRODUCTS
Marketable product, transportable pack, salable pack
PACKAGING MATERIAL
Providing presentation, protection, identification, information, containment, convenience compliance, integrity and stability for a product during storage, transportation display and until it is consumed or throughout its shelf life.
IPQC
Providing accurate, specific and definite description of the procedures to be employed from the receipt of raw materials to the release of the finished dosage form.
CPCSEA GUIDELINES
Role of CPCSEA is to monitor animal experiments through ethics committees set up in institutions (IAEC)
CPCSEA Nominee -important link between CPCSEA and IAEC
IAEC scrutinize all project proposals for experimentation on animals.
The validity of IAEC is for 3 years.
Goods are tangible items which satisfies the need of consumer and there are number of goods that are categorised in different types on the basis of use, ownership etc.
DCGI Applications and Submissions at SUGAM Portal.pptxAkshay Kakde
In January 2016, India's Central Drugs Standard Control Organisation (CDSCO) introduced SUGAM, an online portal, for filing applications of various services.
After that Indian regulatory authorities revised and publish new guideline for Clinical trial as a NDCT rules in March 2019.
Base on NDCT rules, there are number of changes have been made in various applications and their conditions.
This presentation contains basic information for biological products applications and submission through SUGAM Portal. Also, short process flow for approval of drug product process.
vendor validation is important now a days in pharmaceutical industries.
vendor is authorizes seller of raw material,equipment and packaging material to the pharmaceutical organization.
- Video recording of this lecture in English language: https://youtu.be/lK81BzxMqdo
- Video recording of this lecture in Arabic language: https://youtu.be/Ve4P0COk9OI
- Link to download the book free: https://nephrotube.blogspot.com/p/nephrotube-nephrology-books.html
- Link to NephroTube website: www.NephroTube.com
- Link to NephroTube social media accounts: https://nephrotube.blogspot.com/p/join-nephrotube-on-social-media.html
Knee anatomy and clinical tests 2024.pdfvimalpl1234
This includes all relevant anatomy and clinical tests compiled from standard textbooks, Campbell,netter etc..It is comprehensive and best suited for orthopaedicians and orthopaedic residents.
Report Back from SGO 2024: What’s the Latest in Cervical Cancer?bkling
Are you curious about what’s new in cervical cancer research or unsure what the findings mean? Join Dr. Emily Ko, a gynecologic oncologist at Penn Medicine, to learn about the latest updates from the Society of Gynecologic Oncology (SGO) 2024 Annual Meeting on Women’s Cancer. Dr. Ko will discuss what the research presented at the conference means for you and answer your questions about the new developments.
TEST BANK for Operations Management, 14th Edition by William J. Stevenson, Ve...kevinkariuki227
TEST BANK for Operations Management, 14th Edition by William J. Stevenson, Verified Chapters 1 - 19, Complete Newest Version.pdf
TEST BANK for Operations Management, 14th Edition by William J. Stevenson, Verified Chapters 1 - 19, Complete Newest Version.pdf
Title: Sense of Smell
Presenter: Dr. Faiza, Assistant Professor of Physiology
Qualifications:
MBBS (Best Graduate, AIMC Lahore)
FCPS Physiology
ICMT, CHPE, DHPE (STMU)
MPH (GC University, Faisalabad)
MBA (Virtual University of Pakistan)
Learning Objectives:
Describe the primary categories of smells and the concept of odor blindness.
Explain the structure and location of the olfactory membrane and mucosa, including the types and roles of cells involved in olfaction.
Describe the pathway and mechanisms of olfactory signal transmission from the olfactory receptors to the brain.
Illustrate the biochemical cascade triggered by odorant binding to olfactory receptors, including the role of G-proteins and second messengers in generating an action potential.
Identify different types of olfactory disorders such as anosmia, hyposmia, hyperosmia, and dysosmia, including their potential causes.
Key Topics:
Olfactory Genes:
3% of the human genome accounts for olfactory genes.
400 genes for odorant receptors.
Olfactory Membrane:
Located in the superior part of the nasal cavity.
Medially: Folds downward along the superior septum.
Laterally: Folds over the superior turbinate and upper surface of the middle turbinate.
Total surface area: 5-10 square centimeters.
Olfactory Mucosa:
Olfactory Cells: Bipolar nerve cells derived from the CNS (100 million), with 4-25 olfactory cilia per cell.
Sustentacular Cells: Produce mucus and maintain ionic and molecular environment.
Basal Cells: Replace worn-out olfactory cells with an average lifespan of 1-2 months.
Bowman’s Gland: Secretes mucus.
Stimulation of Olfactory Cells:
Odorant dissolves in mucus and attaches to receptors on olfactory cilia.
Involves a cascade effect through G-proteins and second messengers, leading to depolarization and action potential generation in the olfactory nerve.
Quality of a Good Odorant:
Small (3-20 Carbon atoms), volatile, water-soluble, and lipid-soluble.
Facilitated by odorant-binding proteins in mucus.
Membrane Potential and Action Potential:
Resting membrane potential: -55mV.
Action potential frequency in the olfactory nerve increases with odorant strength.
Adaptation Towards the Sense of Smell:
Rapid adaptation within the first second, with further slow adaptation.
Psychological adaptation greater than receptor adaptation, involving feedback inhibition from the central nervous system.
Primary Sensations of Smell:
Camphoraceous, Musky, Floral, Pepperminty, Ethereal, Pungent, Putrid.
Odor Detection Threshold:
Examples: Hydrogen sulfide (0.0005 ppm), Methyl-mercaptan (0.002 ppm).
Some toxic substances are odorless at lethal concentrations.
Characteristics of Smell:
Odor blindness for single substances due to lack of appropriate receptor protein.
Behavioral and emotional influences of smell.
Transmission of Olfactory Signals:
From olfactory cells to glomeruli in the olfactory bulb, involving lateral inhibition.
Primitive, less old, and new olfactory systems with different path
Ozempic: Preoperative Management of Patients on GLP-1 Receptor Agonists Saeid Safari
Preoperative Management of Patients on GLP-1 Receptor Agonists like Ozempic and Semiglutide
ASA GUIDELINE
NYSORA Guideline
2 Case Reports of Gastric Ultrasound
Title: Sense of Taste
Presenter: Dr. Faiza, Assistant Professor of Physiology
Qualifications:
MBBS (Best Graduate, AIMC Lahore)
FCPS Physiology
ICMT, CHPE, DHPE (STMU)
MPH (GC University, Faisalabad)
MBA (Virtual University of Pakistan)
Learning Objectives:
Describe the structure and function of taste buds.
Describe the relationship between the taste threshold and taste index of common substances.
Explain the chemical basis and signal transduction of taste perception for each type of primary taste sensation.
Recognize different abnormalities of taste perception and their causes.
Key Topics:
Significance of Taste Sensation:
Differentiation between pleasant and harmful food
Influence on behavior
Selection of food based on metabolic needs
Receptors of Taste:
Taste buds on the tongue
Influence of sense of smell, texture of food, and pain stimulation (e.g., by pepper)
Primary and Secondary Taste Sensations:
Primary taste sensations: Sweet, Sour, Salty, Bitter, Umami
Chemical basis and signal transduction mechanisms for each taste
Taste Threshold and Index:
Taste threshold values for Sweet (sucrose), Salty (NaCl), Sour (HCl), and Bitter (Quinine)
Taste index relationship: Inversely proportional to taste threshold
Taste Blindness:
Inability to taste certain substances, particularly thiourea compounds
Example: Phenylthiocarbamide
Structure and Function of Taste Buds:
Composition: Epithelial cells, Sustentacular/Supporting cells, Taste cells, Basal cells
Features: Taste pores, Taste hairs/microvilli, and Taste nerve fibers
Location of Taste Buds:
Found in papillae of the tongue (Fungiform, Circumvallate, Foliate)
Also present on the palate, tonsillar pillars, epiglottis, and proximal esophagus
Mechanism of Taste Stimulation:
Interaction of taste substances with receptors on microvilli
Signal transduction pathways for Umami, Sweet, Bitter, Sour, and Salty tastes
Taste Sensitivity and Adaptation:
Decrease in sensitivity with age
Rapid adaptation of taste sensation
Role of Saliva in Taste:
Dissolution of tastants to reach receptors
Washing away the stimulus
Taste Preferences and Aversions:
Mechanisms behind taste preference and aversion
Influence of receptors and neural pathways
Impact of Sensory Nerve Damage:
Degeneration of taste buds if the sensory nerve fiber is cut
Abnormalities of Taste Detection:
Conditions: Ageusia, Hypogeusia, Dysgeusia (parageusia)
Causes: Nerve damage, neurological disorders, infections, poor oral hygiene, adverse drug effects, deficiencies, aging, tobacco use, altered neurotransmitter levels
Neurotransmitters and Taste Threshold:
Effects of serotonin (5-HT) and norepinephrine (NE) on taste sensitivity
Supertasters:
25% of the population with heightened sensitivity to taste, especially bitterness
Increased number of fungiform papillae
Lung Cancer: Artificial Intelligence, Synergetics, Complex System Analysis, S...Oleg Kshivets
RESULTS: Overall life span (LS) was 2252.1±1742.5 days and cumulative 5-year survival (5YS) reached 73.2%, 10 years – 64.8%, 20 years – 42.5%. 513 LCP lived more than 5 years (LS=3124.6±1525.6 days), 148 LCP – more than 10 years (LS=5054.4±1504.1 days).199 LCP died because of LC (LS=562.7±374.5 days). 5YS of LCP after bi/lobectomies was significantly superior in comparison with LCP after pneumonectomies (78.1% vs.63.7%, P=0.00001 by log-rank test). AT significantly improved 5YS (66.3% vs. 34.8%) (P=0.00000 by log-rank test) only for LCP with N1-2. Cox modeling displayed that 5YS of LCP significantly depended on: phase transition (PT) early-invasive LC in terms of synergetics, PT N0—N12, cell ratio factors (ratio between cancer cells- CC and blood cells subpopulations), G1-3, histology, glucose, AT, blood cell circuit, prothrombin index, heparin tolerance, recalcification time (P=0.000-0.038). Neural networks, genetic algorithm selection and bootstrap simulation revealed relationships between 5YS and PT early-invasive LC (rank=1), PT N0—N12 (rank=2), thrombocytes/CC (3), erythrocytes/CC (4), eosinophils/CC (5), healthy cells/CC (6), lymphocytes/CC (7), segmented neutrophils/CC (8), stick neutrophils/CC (9), monocytes/CC (10); leucocytes/CC (11). Correct prediction of 5YS was 100% by neural networks computing (area under ROC curve=1.0; error=0.0).
CONCLUSIONS: 5YS of LCP after radical procedures significantly depended on: 1) PT early-invasive cancer; 2) PT N0--N12; 3) cell ratio factors; 4) blood cell circuit; 5) biochemical factors; 6) hemostasis system; 7) AT; 8) LC characteristics; 9) LC cell dynamics; 10) surgery type: lobectomy/pneumonectomy; 11) anthropometric data. Optimal diagnosis and treatment strategies for LC are: 1) screening and early detection of LC; 2) availability of experienced thoracic surgeons because of complexity of radical procedures; 3) aggressive en block surgery and adequate lymph node dissection for completeness; 4) precise prediction; 5) adjuvant chemoimmunoradiotherapy for LCP with unfavorable prognosis.
Couples presenting to the infertility clinic- Do they really have infertility...Sujoy Dasgupta
Dr Sujoy Dasgupta presented the study on "Couples presenting to the infertility clinic- Do they really have infertility? – The unexplored stories of non-consummation" in the 13th Congress of the Asia Pacific Initiative on Reproduction (ASPIRE 2024) at Manila on 24 May, 2024.
The prostate is an exocrine gland of the male mammalian reproductive system
It is a walnut-sized gland that forms part of the male reproductive system and is located in front of the rectum and just below the urinary bladder
Function is to store and secrete a clear, slightly alkaline fluid that constitutes 10-30% of the volume of the seminal fluid that along with the spermatozoa, constitutes semen
A healthy human prostate measures (4cm-vertical, by 3cm-horizontal, 2cm ant-post ).
It surrounds the urethra just below the urinary bladder. It has anterior, median, posterior and two lateral lobes
It’s work is regulated by androgens which are responsible for male sex characteristics
Generalised disease of the prostate due to hormonal derangement which leads to non malignant enlargement of the gland (increase in the number of epithelial cells and stromal tissue)to cause compression of the urethra leading to symptoms (LUTS
4. Background
It is concerned with planning, organizing and
controlling the flow of materials from their
initial purchase through internal operations to
the service point through distribution.
The aim of pharmaceutical material
management is provide good quality product
with the proper manner that is under the
planning and organization.
5. Aim of Material Management
To Get-
1. The Right quality
2. Right quantity of supplies
3. At the Right time
4. At the Right place
5. For the Right cost
6. Introduction
The prime objective of the pharmaceutical manufacturing
operation to produce finished pharmaceutical product from
active, inactive raw material and various packaging material.
Vendor Selection
Receiving: (Bill, Invoice, Custom Excise gate pass, COA)
Quarantine
Inspection: Cleaned, stacked on non wooden pallet damaged,
abnormality reported to QC.
Storage: RH, RT, FIFO, FEFO, segregated properly to avoid
mix-up
Sampling: Coordinate with QCL
Identification (Label): Status, approved, sampled rejected,
Batch NO, manufacturer’s name
Dispatch: Finished good to customer, rejected material from
supplier etc.
Importance:
Quality material Quality finished product
(R.M. P.M)
7. Purchasing
The purchase of raw materials is an important operation
that should involve staff who have a particular and
thorough knowledge of the products and suppliers.
Starting materials should be purchased only from
approved suppliers and , where possible, directly from
the producer.
The quality parameters should also specify
characteristics like, bulk density, particle size amorphous
or crystalline nature of the material, specificity of
isomers.
8. Cont….
For each consignment, the containers should be checked
for at least integrity of package and seal and for
correspondence between the order, the delivery note, and
the supplier’s labels.
Damage to containers and any other problem that might
adversely affect the quality of a material should be
recorded and reported to the quality control department
and investigated.
R.M. and P.M. should only be purchased by buyer who
are trained and possess sufficient technical knowledge.
9. Raw material
Supplier of the received material should have his name listed in companies
approved vendors list. Such list should available with in receiving
department.
● Approved Vendor: RM is ensured that has come from approved supplier,
list of vendor is available in stores
● Checking:
i) Name of product
ii) Batch No.
iii) MFG. Date EXP Date.
iv) Quantity Received
v) Condition of container
vi) Name of material and supplier
After receiving of raw material should be check –
i) Name of Supplier.
ii) Name of the Product.
iii) Batch Number.
iv) Mfg. Date & Exp. Date.
v) Quantity Received or No of containers or Packages.
vi) Condition of Container and Material.
10. Cont….
All containers should be cleaned externally and damage
if any report to Q.C. department . all the received have
proper document such as bills, gate passes, log book
records and COA.
From the received sample material place in sampling
area with proper label by Q.C person.
All received material must have identified label status
e.g.
i) Received Sampled.
ii) Approved.
iii) Rejected.
● Material Identification like
i) Product Name.
ii) Batch No.
iii) Code No.
iv) Sterility Status.
11. Cont…
If one delivery of material is made up of different
batches ,each must be considered as separate for
sampling ,testing and release.
Material storage room should have properly
labeled and have following information
Name and internal code number.
Batch no given by supplier and given by receiver after
analysis and release.
Status of the contents (e.g. quarantine, on test, released,
rejected, returned, recalled).
Retest and expiry date of the product.
Appropriate special storage condition.
12. Cont….
Only starting materials released by the quality
control department and within their shelf-life
should be used.
Starting materials should be dispensed only by
designated persons.
Following a written procedure, to ensure that the
correct materials are accurately weighed or
measured into clean and properly labeled
containers.
13. Cont….
Each dispensed material and its weight or
volume should be independently checked and
the recorded.
All the dispensed material have proper label and
record in the log book in chronological order .
The record must have following points.
i) Name of the product and Batch no. for which material
is dispensed.
ii) Time and date of starting material and completion of
dispensing activity.
iii) Name of weigher and checker.
14. Packaging Materials
It is having four types.
Primary Packaging Material
Material is direct contact with product
e.g. Bottles, ampoules, vials, foils.
Secondary Packaging Material
Material which comes contact with primary product.
e.g. Label, carton.
Printed Packaging Materials
All packaging materials which have any thing printed on
it. Material like labels, cartons, foils.
Tertiary and other Packaging Material
All other packaging material other than those cover
Primary, Secondary, Printed material.
e.g. Shipper, Box.
15. Cont….
All the secured area like storage room having
authorised access.
Maintain log book records for access.
Each delivery of packaging material have
unique code or batch no.
All the packaging should be checked by
packaging department.
16. Intermediate and Bulk Products
This are the starting material in the process but not
converted to finished product.
e.g. I) Granules ready for compression.
II) Compressed tablets, awaiting coating.
III) Filtered or unfiltered liquid for oral injectable.
Handling By :
Production dept.
Storage: Temp :
RH class is critical.
Receipt:
When purchased, to be treated like RM
17. Finished Products
Held in quarantine until their final release
Then stored as unable stock under suitable storage
conditions
Evaluation and documentation necessary for
release
Product release procedure
Batch record review and related procedure
18. Rejected and recovered materials
These are the materials at any stage which have
been tested against set of predefined and found
not meeting the specification completely.
Clearly marked
Stored separately in restricted areas
Action-
Return to suppliers or destroyed
Action approved by authorised personnel maintain
records
19. Cont….
Recovered materials should be exceptional cases
Only if
Risk involved have been evaluated and final product will
not be affected
Specification are met
Defined procedure
Record maintain and new batch no.
Such products stored in separate area in industry
painted in Red color.
20. Cont….
Recovered products normally between 5-10 %
are added in fresh batches including any
possible effects on shelf life.
The record should be maintained by authorised
personnel or Q.C. department
21. Recalled Products
These are the product which are sold or
distribute which recall after some time.
It is due to improper handling of material during
process.
Stored in secure area with proper label
Accessible by authorised personnel
Record should be maintain
Decision taken on their fate
22. Returned goods
These are the goods returned from market for
various reasons
Q.C. department evaluates physical
examinations and quality of goods received.
Decision on their fate
Reprocessed
Recovered
Need to be destroyed
24. Reagent and culture media
Records for receipt or preparation
Reagents
Preparation according to SOP
Appropriate labeling
i) Name of reagent
ii) Conc (1N, 2N 20 % etc.)
iii) Standardization factor
iv) Shelf life / use before
v) Date of re-standardization
vi) Storage condition-
vii) Sign: Prepared by, Checked by
25. Cont….
● Culture media
Positive and negative controls should be applied
to verify stability of culture media
26. Waste materials
Pharmaceutical manufacturing operation generate
lot of waste material
It is of two types
Trash- No resale value and disposed by proper
method depend upon nature of trash
Scrap- Have resale value and maybe sold to scrap
dealers
1. Paper .
2. Aluminium Foils.
3. Plastic.
4. Glass.
5. Metallic containers.
Toxic substance and flammable material storage
stored at safe area
27. Reference Standards
These are the official reference standards
Reference standard are prepared by the
producers should be tested released and stored
in the same way official standards
Stored in secure area
Accessible by authorised personnel
Record should be maintained
It is only used for the purpose described in the
appropriate monograph
28. Cont….
Secondary reference standard
Appropriate label
Name
Batch, lot number
Date of preparation
Shelf life
Storage condition
29. Miscellaneous materials
This type of materials do not falls under the
category R.M/P.M
Materials like
Rodenticide, insecticide, fumigating agents
Sanitizing materials
No contamination risk to equipment raw materials,
packaging materials, in-process materials or finish
products
30. References
Pharmaceutical Quality Assurance by Manohar
Potdar Page no-4.1- 4.18.
Quality Assurance Volume II second updated
edition Page no.34 - 39