This document discusses the basic principles of good manufacturing practices (GMP) for materials used in pharmaceutical manufacturing. It covers requirements for different types of materials including starting materials, packaging materials, finished products, rejected materials, and more. Specific requirements addressed include purchasing, receiving, identification, storage conditions, dispensing, labeling, and control of these materials. Problems associated with materials are examined, along with how to properly manage materials to ensure quality and avoid issues.
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1. Module 11 | Slide 1 of 25 January 2006
Basic Principles of GMP
Materials
14
2. Module 11 | Slide 2 of 25 January 2006
Materials
Objectives
To review specific requirements for each type of material:
Starting materials
Packaging materials
Intermediate and bulk products
Finished products
Rejected and recovered materials
Recalled products
Returned goods
Reagents and culture media
Reference standards
Waste materials
Miscellaneous materials
To examine (in groups) the problems associated with materials,
and how to overcome them
3. Module 11 | Slide 3 of 25 January 2006
Materials
Principle
Objective of the pharmaceutical manufacturer
produce finished products for patient's use from a
combination of materials
Materials combined
Active pharmaceutical ingredients and
Excipients (auxiliary materials)
Packaging materials
Materials include also
Gases, solvents, reagents, process aids, etc.
Special attention 14.1, 14.2
4. Module 11 | Slide 4 of 25 January 2006
14.3–14.6
Materials
General requirements for materials
Materials for cleaning, lubrication, and pest control
Not in direct contact with product
Suitable grade, e.g. food grade if possible
All incoming materials and finished products
quarantined after receipt or processing
– until released for use or distribution
stored
– under appropriate conditions
– orderly fashion (batch segregation)
– materials management
– stock rotation (FEFO)
Water – suitable for use
5. Module 11 | Slide 5 of 25 January 2006
14.7 – 14.10
Materials
Starting Materials – I
Purchasing – important operation
From approved suppliers – if possible, direct from the
manufacturer
Specifications for materials
Consignment checks
Integrity of package
Seal intact
Corresponds with the purchase order
Delivery note
Supplier’s labels
Cleaned and labelled with information
6. Module 11 | Slide 6 of 25 January 2006
14.11 – 14.14
Materials
Starting Materials – II
Different batches in one delivery/consignment
Starting materials labelled
name and internal code
Supplier's batch number(s) and manufacturer's on receipt
Status (e.g. quarantine, on test, etc.)
expiry date or retest date
Role of validated computer systems
"Sampled" containers identified
7. Module 11 | Slide 7 of 25 January 2006
Basic Principles of GMP
8. Module 11 | Slide 8 of 25 January 2006
Basic Principles of GMP
Damage to and problems
with containers
Recorded and reported
to QC
Investigated
9. Module 11 | Slide 9 of 25 January 2006
Materials
Examples of Labelling of Starting Materials
Name of
Material and/or
internal code
Control/
Batch No.
Status
Quarantined/Released/Rejected
(Colours may be used)
Expiry date or
retest date
Date Signature
10. Module 11 | Slide 10 of 25 January 2006
14.15 – 14.18
Materials
Starting Materials – III
Use only QC released material if within shelf-life
Dispensing
designated persons
written procedure
Correct materials accurately weighed
clean, properly labelled containers
Independent checks and record
material and weight or volume
Dispensed material
kept together and labelled
11. Module 11 | Slide 11 of 25 January 2006
Basic Principles of GMP
12. Module 11 | Slide 12 of 25 January 2006
14.25–14.20
Materials
Packaging materials - I
Primary and printed packaging materials
purchasing, handling and control
– as for starting materials
Printed packaging materials: particular attention
Stored in secure conditions with authorized access
Roll labels where possible in place of cut labels
Loose materials stored and transported in separate, closed
containers - to avoid mix-ups
Issued by designated personnel
SOP for issue and returns
13. Module 11 | Slide 13 of 25 January 2006
Basic Principles of GMP
14. Module 11 | Slide 14 of 25 January 2006
14.21 – 14.23
Materials
Printed and primary packaging materials - II
Each delivery or batch: specific reference number or
identification mark
Delivery to packaging department
Check quantity, identity and conformity to packaging
instructions
Outdated or obsolete material
Destroyed
Disposal record
15. Module 11 | Slide 15 of 25 January 2006
Basic Principles of GMP
Intermediate and bulk
products
Kept under appropriate
conditions
If purchased as such
Handled on receipt as
though these are
starting materials
14.24 – 14.25
16. Module 11 | Slide 16 of 25 January 2006
Basic Principles of GMP
Finished products
Held in quarantine until their
final release
Then stored as usable stock
under suitable storage
conditions
Evaluation and
documentation necessary
for release
Product release procedure
Batch record review and
related procedure
14.26 – 14.27
17. Module 11 | Slide 17 of 25 January 2006
14.28
Materials
Rejected, reworked and recovered materials
Rejected materials and products
Clearly marked
Stored separately in restricted areas
Action – returned to supplier/destroyed, etc. in timely manner
Action approved by authorized personnel – records
maintained
18. Module 11 | Slide 18 of 25 January 2006
14.29 – 14.30
Materials
Rejected, reworked and recovered materials
Rework and recovery
Should be exceptional cases
Only if:
– Risks involved have been evaluated and the quality of
final product will not be affected
– Specifications are met
– Defined procedure
– Records maintained
– New batch number
additional testing to be considered by QC
19. Module 11 | Slide 19 of 25 January 2006
14.32 – 14.33
Materials
Recalled products and returned goods
Recalled products
Identified
Stored separately
Secure area - access controlled
Decision taken on their fate
Returned goods
Destroyed unless suitable quality
SOP: decision regarding their fate (relabelling, resale, etc.)
– Consider: nature of product, special storage conditions,
condition, history, time elapsed since issue
Action taken to be recorded
20. Module 11 | Slide 20 of 25 January 2006
14.34 – 14.36
Materials
Reagents and culture media
Records for receipt or preparation
Reagents
Preparation in accordance with SOP
Appropriately labelled:
– concentration, standardization factor, shelf-life, date that
restandardization is due, storage conditions
– signed and dated
Culture media
positive and negative controls each time prepared and used
Inoculum size appropriate
21. Module 11 | Slide 21 of 25 January 2006
14.37 – 14.40, 14.42
Materials
Reference standards - I
Official reference standards
Use preferable whenever these exist
Only for the purpose as per monograph
Storage conditions
Reference standards prepared by the producer
Tested, released and stored in the same way as official
standards
In a secure area
A responsible person
Secondary or working standards
Appropriate checks and tests at regular intervals
Standardized against official reference standards – initially and
at regular intervals
22. Module 11 | Slide 22 of 25 January 2006
14.41, 14.43
Materials
Reference standards - II
Reference standards labelled with information including
Name
Batch, lot or control number
Date of preparation
Shelf-life
Potency
Storage conditions
Stored and used in an appropriate manner
23. Module 11 | Slide 23 of 25 January 2006
14.44
Materials
Waste materials
Waste materials
proper and safe storage when awaiting disposal
toxic substances and flammable materials:
– in suitably designed, separate, enclosed areas as per
national legislation
not to be allowed to accumulate
– collected in suitable containers for removal to collection
points
– safe and sanitary disposal
– regular and frequent intervals
24. Module 11 | Slide 24 of 25 January 2006
14.45
Materials
Miscellaneous materials
Miscellaneous
Rodenticides, insecticides, fumigating agents
Sanitizing material
No contamination risk to equipment, starting materials,
packaging materials, in-process materials, finished products
25. Module 11 | Slide 25 of 25 January 2006
Materials
Group session
List specific aspects of GMP requirements, in relation to the
groups of materials listed below, that you would assess when
inspecting a manufacturer
Printed packaging materials
Thermolabile materials
Water
Sterile materials
Identify three materials that present problems in your
experience
What are some of the problems that you have experienced
before and during inspection of materials?
Hinweis der Redaktion
<number>
जुलाइ 28, 2014
In this module we shall be looking at the GMP guidelines for all aspects relating to the handling and processing and storage of materials. This includes guidance on the purchasing, receiving, storage and distribution of materials, finished product and waste materials.
We will be looking at the different types of materials, and materials at different stages in production processes.
The programme is as follows:
Presentation 45 minutes
Group session60 minutes
Plenary session30 minutes
Test30 minutes
All timings are approximate
<number>
जुलाइ 28, 2014
Our main objective in this session is to review with you all the key issues relating to materials mentioned in the WHO GMP text, Part One. First of all, we will be discussing the general principles of GMP for materials. We will then review in turn different materials including:
Starting materials
Packaging materials
Intermediate and bulk products
Finished products
Rejected and recovered materials
Recalled products
Returned goods
Reagents and culture media
Reference standards
Waste materials
Miscellaneous materials.
We will then have a group discussion where we will be looking at specific issues and problems relating to materials, that you may encounter during your inspections.
<number>
जुलाइ 28, 2014
The main objective of a pharmaceutical factory is to produce finished products from a combination of materials. The way in which the factory is organised to look after all the materials is therefore of vital importance to the quality of the finished product. Special attention must be given to the requirements and guidelines regarding GMP for materials, all stages of production and quality control testing. It includes:
Specifying the materials (specifications)
Purchasing materials
Receiving materials
Storing materials
Dispensing
Using materials for production
Storing the finished product
Distributing the finished product
Dealing with all the reagents and standards used in testing
Dealing with the waste materials that arise from the processes.
Non-compliance with GMP guidelines could result in manufacturing products not containing the right materials, or the right quality of materials.
This is turn can result in products being rejected or recalled from the market.
<number>
जुलाइ 28, 2014
In general, all incoming materials and finished products should be quarantined immediately after receipt for processing, until they are released for use or for distribution.
The manufacturer of starting materials normally specifies the storage conditions for raw materials. The manufacturer of the finished product must be aware of the storage conditions for the materials used in the factory, and must ensure that the materials are stored under appropriate conditions. Inspectors should check that the storage areas are maintained at the correct temperature and relative humidity specifications. The conditions should thus be controlled, monitored and recorded. Review the SOP and records for these parameters and ensure that the materials are stored in the correct environment by verifying the label information and environment control records
All containers of materials should be stored in an orderly way to prevent cross-contamination and mix-ups. Segregation between products is necessary to prevent possible cross-contamination. Segregation of different batches of the same product is also recommended to promote stock rotation.
Ensure that the manufacturer also has a system of controlling stock. Different systems exist for materials management, including a bin card system and bin locations, and computerized stock control. It is important to look at the process of issuing of material as well as the return of unused material back to the store.
During the inspection, also ensure that materials that have the shortest expiry date, are used first (First-in-first-out (FIFO) or EEFO (Earliest Expiry, First Out).
<number>
जुलाइ 28, 2014
The purchasing of starting or raw materials is an important activity of the manufacturer. It is not considered as merely an administrative activity. The inspector should ensure that the staff that are responsible for purchasing of materials, have sufficient knowledge of the materials, products and suppliers of the materials.
During your inspection, you should also verify that the materials are only bought from the specified suppliers. This is normally specified in the registration dossiers, or approved suppliers list, or specification of the material. To ensure that the correct materials are supplied, manufacturers are advised to rather purchase materials direct from the manufacturer of the material, and, where possible, not from an agent or broker.
It is advisable that the manufacturer discusses the specification for the raw materials with the manufacturer. This could ensure that the correct quality of material is supplied to the manufacturer of the finished products. All aspects relating to the production and control of the starting material, including the handling, labelling and packaging requirements can be agreed upon. Aspects relating to complaints and rejection procedures can also be discussed.
During your inspection, you will assess how the manufacturer receives materials from the suppliers. The procedure followed (check written SOP against actual procedure), should include checking the consignment for integrity of the containers or package, that the seals are intact, and that the information on the order, delivery note and label on the containers correspond with each other. All containers should be cleaned when necessary before these are taken into the premises, and should be properly labelled with relevant information (e.g. status, name of the material, reference code etc).
<number>
जुलाइ 28, 2014
Make sure that the manufacturer checks the containers for any damage and possible contamination and cross-contamination.
You should also assess how the manufacturer deals with a consignment of material, that is made up of different batches of the same material. It is required that the different batches be considered separate for sampling, testing and release. You should verify this by recording any materials with different batches that had been received in one consignment (by checking the shelf, or the goods received register), and comparing the sampling, testing and release results in the laboratory.
Starting materials in the storage area should be properly labelled. The label should bear at least:
- the name of the material and an internal reference code
- batch number given by the supplier, and manufacturer’s batch or receiving number
- the status of the material (e.g. quarantine, released, rejected)
- expiry date of the material, or a re-test date. (See also point 18.51 of the WHO Text, GMP for Active Pharmaceutical Ingredients (bulk drug substances)).
Some manufacturers make use of computerized systems. In such cases, the above-mentioned information is not always on the label. However, in such cases, you have to inspect the computer system and ensure that the system has been validated.
As the materials normally have to be sampled and tested against the specification, a procedure has to be followed for sampling the material. The containers from which samples were taken, should be identified (e.g. a label).
<number>
जुलाइ 28, 2014
There should be appropriate procedures or measures to ensure
the identity of the contents of each container of starting material.
Bulk containers from which samples have been drawn should be
identified.
Only starting materials released by the quality control department
and within their shelf-life should be used.
Sampling tools/equipment/utencils should be used to ensure that representative samples are taken for testing.
<number>
जुलाइ 28, 2014
Any damage to containers received (that could possibly have an adverse effect on the quality of the material), should be recorded on receipt and reported to the quality control section. It should also be investigated before a decision is made regarding the release or rejection of the material.
<number>
जुलाइ 28, 2014
This is an example of a status label
<number>
जुलाइ 28, 2014
The quality control department is responsible for sampling, testing, release and rejection of materials. It is important to verify that the manufacturer only uses materials in production that had been released by the quality control section. The materials must also be within their shelf-life.
The process of weighing or dispensing materials for production, should be done in accordance with an approved procedure. Only designated persons, who are qualified and trained, should dispense materials for production. Dispensing is a critical stage in the manufacturing process and should be properly controlled. It is important that the correct material, and the correct quantity of material is dispensed (accurately weighed) for the product to be manufactured.
As the materials are taken from labelled containers when dispensed, it should be weighed out into clean, labelled containers to ensure that the identification of the material isn’t lost. The label should reflect all the relevant information. There should be a second person who performs an independent check of the dispensing activity, to ensure that correct material and the correct weight (or volume) of the material had been dispensed. This check should be recorded e.g. on the batch manufacturing document or weighing ticket (label).
You can evaluate the SOP for dispensing, and assess whether the SOP is complete and will ensure that the dispensing activity complies with GMP requirements to prevent contamination, cross-contamination and mix-ups.
Materials dispensed for a particular batch of product, should be kept together (e.g. on a pallet) and properly labeled to identify the product and batch it was weighed out for.
<number>
जुलाइ 28, 2014
Discuss dispensing of materials
<number>
जुलाइ 28, 2014
Packaging materials should also be controlled by the manufacturer. Specific attention should be given, and controls exercised for primary packaging materials, and printed packaging materials. The product will come into direct contact with the primary packaging materials. Special care should be given to the quality of these materials such as ampoules, bottles and foil used in blister or strip packing. The prevention of mix-ups of printed packaging materials such as leaflets, labels and cartons is of great importance. The guidelines recommend that the purchase, handling and control of primary and printed packaging materials should be as for starting materials. (There should thus be approved suppliers and specifications for these materials. They should be quarantined on receipt, sampled and tested before release or rejection).
The access to printed packaging material should be controlled to prevent any unauthorized access. Cut labels and other loose printed packaging materials should be stored and transported in separate, closed (sealed) containers to prevent possible mix-ups. Only designated personnel should issue printed packaging materials to production. The issue (and return when allowed) of printed packaging materials should be done in accordance with written SOPs.
<number>
जुलाइ 28, 2014
Discuss the:
issuing of materials,
reconciliation,
storage and transport in closed containers to prevent mix-ups
<number>
जुलाइ 28, 2014
It is recommended that manufacturers allocate reference numbers to materials. These reference numbers are unique for each batch or consignment of material and assist in the traceability of material.
Personnel in the packaging department should check materials delivered to the department to ensure that the correct quantity of the correct material, complying with the packaging instructions, had been issued.
All outdated or obsolete primary packaging material and printed packaging material should be destroyed in accordance with an SOP. The destruction should be recorded.
<number>
जुलाइ 28, 2014
Kept under appropriate conditions
If purchased as such:
Handled on receipt as though these are starting materials
<number>
जुलाइ 28, 2014
Held in quarantine until their final released
Then stored as usable stock under suitable storage conditions
Evaluation and documentation necessary for release
Product release procedure
Batch record review and related procedur
<number>
जुलाइ 28, 2014
Rejected materials
When materials are rejected, they should be clearly marked as such. Rejected materials should be stored separately and access to the area should be controlled. This is to prevent the accidental use or distribution of rejected materials.
Manufacturers can return rejected materials to the suppliers, destroy the materials or reprocess the rejected materials. The action the manufacturer initiates, should however be described and defined in a procedure. The action to be taken should be approved by authorized personnel. The action and approval must be recorded.
Reprocessing
Reprocessing of rejected materials should only be done in exceptional cases. It should only be allowed if the quality of the product is not negatively affected. The product must still comply with the specifications. During your inspections, you should assess the SOP to ensure that it clearly describes the manufacturer’s policy and procedure for reprocessing, as well as who will be responsible for evaluating the risks that are involved in reprocessing rejected material. Remember, proper and complete records should be maintained for reprocessed materials. A reprocessed batch should be given a new batch number. The manufacturer should also consider additional testing of reprocessed materials, e.g. stability testing of the batch.
<number>
जुलाइ 28, 2014
Rejected materials
When materials are rejected, they should be clearly marked as such. Rejected materials should be stored separately and access to the area should be controlled. This is to prevent the accidental use or distribution of rejected materials.
Manufacturers can return rejected materials to the suppliers, destroy the materials or reprocess the rejected materials. The action the manufacturer initiates, should however be described and defined in a procedure. The action to be taken should be approved by authorized personnel. The action and approval must be recorded.
Reprocessing
Reprocessing of rejected materials should only be done in exceptional cases. It should only be allowed if the quality of the product is not negatively affected. The product must still comply with the specifications. During your inspections, you should assess the SOP to ensure that it clearly describes the manufacturer’s policy and procedure for reprocessing, as well as who will be responsible for evaluating the risks that are involved in reprocessing rejected material. Remember, proper and complete records should be maintained for reprocessed materials. A reprocessed batch should be given a new batch number. The manufacturer should also consider additional testing of reprocessed materials, e.g. stability testing of the batch.
<number>
जुलाइ 28, 2014
Recalled products
There may be occasions when a manufacturer has to recall a product or a batch of a product from the market. There could be various reasons for the recall, such as a quality defect. Products that have been recalled from the market, should be identified (labelled). It is recommended that recalled products be stored separately in areas where access is controlled. This is to ensure that recalled products are not issued or sold again by accident. Recalled products should be kept in this controlled area, until a final decision is made by a designated or responsible person regarding the fate of the product. The decision regarding the fate of recalled products should be taken as soon as possible. The process of handling, and storage of recalled products should be in compliance with the company’s standard operating procedure. (See also the module on recalls).
Returned goods
Products that have left the premises of the manufacturer, can be returned to the manufacturer for various reasons. Products returned to the supplier must be handled in accordance with an SOP. Returned goods should preferably be destroyed.
The quality control department can critically assess the product to determine whether the quality of the product is still satisfactory, and recommend that the product be sold again, relabeled or reprocessed. In considering this, the nature of the product must be considered (e.g. dosage form), storage condition requirements (e.g. fridge storage), the condition and history of the product, as well as the time lapse since sale to return to the manufacturer. If the product was supposed to be stored between 2 and 8 degrees Celsius, and it had been in the distribution chain for a long time, the manufacturer could have difficulty in assessing whether the product had not been exposed to conditions that could have adversely affected the product.
<number>
जुलाइ 28, 2014
All reagents and culture media should be recorded upon receipt or preparation. Some manufacturers record the relevant information in registers, others record the information in computer systems.
Reagents
Written standard operating procedures should be followed for the preparation of reagents, when these are not purchased from suppliers. All reagents and volumetric solutions should be appropriately labelled. Ensure that the labels indicate at least the concentration, the standardization factor, the shelf-life, the due date for re-standardization and the storage conditions of the reagent. It is also necessary to check whether the analyst that prepared the reagent had signed and dated the label. You can use this information to verify who prepared the reagent, and whether the SOP was followed by verifying the calculations in the analyst log book.
Culture media
Manufacturers have to ensure that the culture media they will use is suitable for the intended use. However, false results indicating micro contamination, are also not desired. Verify whether the manufacturer applies both positive and negative controls on culture media.
The size of the inoculum used in positive controls should be appropriate to the sensitivity required.
<number>
जुलाइ 28, 2014
Manufacturers make use of reference standards to test products and materials.
An important part of the inspection in the laboratory, will be to assess hoe the laboratory handles, stores and uses reference standards.
Manufacturers should make use of reference standards, available as official reference standards. Official reference standards should be used only for the purpose described in the monograph (e.g. pharmacopoeia). Official reference standards should be stored under conditions as specified by the supplier to ensure that the conditions will not adversely affect their quality, resulting in inaccurate or unreliable results.
Reference standards prepared by the producer should be tested, released (or rejected) and stored in the same way as official standards. The standards should be stored in a secure area and a responsible person should be designated to control the reference standards.
The manufacturer may establish secondary or working standards by applying appropriate checks and tests on materials to be used as reference standards. These tests and checks must be performed on a regular basis to ensure standardization (and suitability of use of the secondary or working standard). All working standards should be based on official reference standards (when available).
(The trainer should refer the attendees to Annex 3 of the WHO Technical Report Series, No 885 (fifty-fifth report, published in 2599, regarding “General guidelines for the establishment, maintenance and distribution of chemical reference standards”).
<number>
जुलाइ 28, 2014
Manufacturers make use of reference standards to test products and materials.
An important part of the inspection in the laboratory, will be to assess hoe the laboratory handles, stores and uses reference standards.
Manufacturers should make use of reference standards, available as official reference standards. Official reference standards should be used only for the purpose described in the monograph (e.g. pharmacopoeia). Official reference standards should be stored under conditions as specified by the supplier to ensure that the conditions will not adversely affect their quality, resulting in inaccurate or unreliable results.
Reference standards prepared by the producer should be tested, released (or rejected) and stored in the same way as official standards. The standards should be stored in a secure area and a responsible person should be designated to control the reference standards.
The manufacturer may establish secondary or working standards by applying appropriate checks and tests on materials to be used as reference standards. These tests and checks must be performed on a regular basis to ensure standardization (and suitability of use of the secondary or working standard). All working standards should be based on official reference standards (when available).
(The trainer should refer the attendees to Annex 3 of the WHO Technical Report Series, No 885 (fifty-fifth report, published in 2599, regarding “General guidelines for the establishment, maintenance and distribution of chemical reference standards”).
<number>
जुलाइ 28, 2014
Waste materials
In any manufacturing environment, there is a considerable amount of waste materials. This includes waste materials resulting from testing in laboratories.
Waste materials can not always be taken away from the premises, or destroyed immediately. The manufacturer should therefor make provision for proper and safe storage of waste material.
Some waste can contain toxic substances. Toxic substances and flammable materials should be stored in suitably designed, separate, enclosed cupboards. You should also assess whether these materials are stored in compliance with the legislation where you are inspecting.
It is important to make sure that waste materials are not allowed to accumulate. Waste materials should be removed at regular and frequent intervals. You can inspect the receptacles and assess the SOP for storage and disposal of waste to verify whether the manufacturer has policy regarding the removal and safe disposal of waste. Verify whether the manufacturer complies with its own policy and SOP. You should also make sure that the process of disposal is done safely and in a sanitary manner.
Miscellaneous
There are also several other miscellaneous materials used in the manufacturing site. These include rodenticides, insecticides, fumigating agents, and sanitizing materials. These materials are used for specific purposes and are often toxic or hazardous. Ensure that there is no possibility that these materials can contaminate equipment, starting materials, intermediate or bulk products when these materials are used or stored on the premises.
<number>
जुलाइ 28, 2014
Waste materials
In any manufacturing environment, there is a considerable amount of waste materials. This includes waste materials resulting from testing in laboratories.
Waste materials can not always be taken away from the premises, or destroyed immediately. The manufacturer should therefor make provision for proper and safe storage of waste material.
Some waste can contain toxic substances. Toxic substances and flammable materials should be stored in suitably designed, separate, enclosed cupboards. You should also assess whether these materials are stored in compliance with the legislation where you are inspecting.
It is important to make sure that waste materials are not allowed to accumulate. Waste materials should be removed at regular and frequent intervals. You can inspect the receptacles and assess the SOP for storage and disposal of waste to verify whether the manufacturer has policy regarding the removal and safe disposal of waste. Verify whether the manufacturer complies with its own policy and SOP. You should also make sure that the process of disposal is done safely and in a sanitary manner.
Miscellaneous
There are also several other miscellaneous materials used in the manufacturing site. These include rodenticides, insecticides, fumigating agents, and sanitizing materials. These materials are used for specific purposes and are often toxic or hazardous. Ensure that there is no possibility that these materials can contaminate equipment, starting materials, intermediate or bulk products when these materials are used or stored on the premises.
<number>
जुलाइ 28, 2014
Possible issues:
Printed packaging material:
Purchasing, Specifications, Receiving, Sampling, Mix-ups, Batch integrity, Storage and transport, issue and returns to production and stores.
Thermolabile materials
Purchasing, Specifications, Receiving, Sampling, Storage and transport.
Water:
Quality of water, types of water. Water purification system (DI, RO, WFI)
Sterile materials
Purchasing, Specifications, Receiving, Sampling, Prevention of contamination and cross-contamination, Batch integrity, Storage, dispensing, bio-burden control and determination.