Sản xuất gia công và kiểm nghiệm | Tài liệu GMP
•
1 like•552 views
Tài liệu GMP được chia sẻ bởi GMPc Việt Nam - Nhà tư vấn Sáng tạo, Chuyên nghiệp, Toàn diện Dự án Nhà máy GMP (EU, PIC/S, WHO, ASEAN), ISO 13485:2012, ISO/IEC 17025:2005, ISO 15189:2012, ISO 15378:2011, ISO 9001:2008
Recommended
More Related Content
Viewers also liked
Viewers also liked (17)
More from Công ty cổ phần GMPc Việt Nam | Tư vấn GMP, HS GMP, CGMP ASEAN, EU GMP, WHO GMP
More from Công ty cổ phần GMPc Việt Nam | Tư vấn GMP, HS GMP, CGMP ASEAN, EU GMP, WHO GMP (20)
Recently uploaded
Recently uploaded (20)
Sản xuất gia công và kiểm nghiệm | Tài liệu GMP
- 1. Module 6 | Slide 1 of 14 January 2006 Contract Production and Analysis Section 7 Basic Principles of GMP
- 2. Module 6 | Slide 2 of 14 January 2006 Contract Production and Analysis Objectives To review general issues To understand the responsibilities of: Contract giver Contract acceptor To understand the contract
- 3. Module 6 | Slide 3 of 14 January 2006 7.1 – 7.4 Contract Production and Analysis Principle Contract production and analysis must be correctly defined, agreed, and controlled: To avoid misunderstandings that could result in unsatisfactory products, work or analysis A written contract should clearly describe: Each party's duties and responsibilities including audits Clearly state how the authorized person, when exercising his or her full responsibility, releases each batch or issues certificate of analysis
- 4. Module 6 | Slide 4 of 14 January 2006 7.5 Contract Production and Analysis Responsibilities of the Contract Giver (1) Must assess competence of contract acceptor to do the work or analysis Must assess contract acceptor for compliance with GMP Approve contracted activities
- 5. Module 6 | Slide 5 of 14 January 2006 7.6 – 7.7 Contract Production and Analysis Responsibilities of the Contract Giver (2) Provide all the necessary information to the contract acceptor in order to: have the operations carried out correctly in accordance with the manufacturing authorization and other legal requirements be fully aware of any problems with the product, work, tests that might pose a hazard to premises, equipment, personnel, other materials or other products Ensure that materials and products supplied by the contract acceptor are in compliance with specifications, or Products are released by the authorized person
- 6. Module 6 | Slide 6 of 14 January 2006 7.8 Contract Production and Analysis Responsibilities of the Contract Acceptor (1) Must have a manufacturing authorization Competence: Have the necessary facilities, premises and equipment to undertake the work Staff should have the necessary qualifications, knowledge, training and experience to be able to do the work
- 7. Module 6 | Slide 7 of 14 January 2006 7.9 - 7.10 Contract Production and Analysis Responsibilities of the Contract Acceptor (2) No subcontracting without prior approval to a third party (The contract giver must be able to undertake audits needed to reassure that the third party is competent and approve subcontracting) All the required information should be given to the third party No conflicting activities or practices that could adversely affect the product(s)
- 8. Module 6 | Slide 8 of 14 January 2006 7.11 - 7.14, 7.17 Contract Production and Analysis The Contract (1) Written: Defining each party’s responsibilities Technical aspects drawn up by competent persons with knowledge in pharmaceutical technology, analysis and GMP Batch release/COA issued by the authorized person, compliance with marketing authorization Production and analysis arrangements as in marketing authorization – agreed to by both parties Describe handling of rejected materials
- 9. Module 6 | Slide 9 of 14 January 2006 7.15, 7.17 Contract Production and Analysis The Contract (2) Who is responsible for: Material purchasing, testing and releasing Production and quality control including in-process quality control (IPQC) Sampling and analysis In the case of contract analysis: Who takes the sample? Where is the sample taken? Describe procedure if a tested product must be rejected
- 10. Module 6 | Slide 10 of 14 January 2006 7.16 Contract Production and Analysis The Contract (3) The contract giver should keep or have access to: Reference standards and retention samples Records of: manufacturing analysis distribution In case of recalls, complaints and suspected defects: all relevant records described in SOP
- 11. Module 6 | Slide 11 of 14 January 2006 Contract Production and Analysis Group Session Identify the items that should be included in a contract Why should these items be included? What should you do if you find a contract that does not include these items?
- 12. Module 6 | Slide 12 of 14 January 2006 Contract Production and Analysis Possible Issues – I Owners insist on using unsuitable facilities Owners insist on using relatives’ facilities No time to validate new facilities Contract acceptor takes on inappropriate new product
- 13. Module 6 | Slide 13 of 14 January 2006 Contract Production and Analysis Possible Issues – II Contract acceptor does not have all specified equipment Contract acceptor uses incorrect equipment Contract acceptor does not follow agreed procedures
- 14. Module 6 | Slide 14 of 14 January 2006 Contract Production and Analysis Possible Issues – III Contract acceptor uses an alternative material supplier Contract acceptor working with out-of-date specifications
Editor's Notes
- <number> जुलाइ 28, 2014 This session deals with contract production and analysis. It is a half-day session, split into activities as follows: Presentation30 minutes Group session60 minutes Plenary feedback30 minutes Test paper30 minutes The global industry is changing its shape through rationalization, mergers and acquisitions. Companies are increasingly considering the use of other manufacturers to produce or manufacture their products. Companies are also finding that they do not have the technology or expertise to manufacture certain new special dosage forms. In some cases, financial targets mean that companies are not using manufacturing as a core business process. This means that the importance of contract manufacturing and testing of products is also increasing. It may also mean that companies no longer have the technical expertise in-house to fulfil all the requirements for GMP. Increasingly many companies in developing countries are used as contract accepters. It is essential for everyone concerned to understand the principles involved and the detailed mechanisms required for managing contract work properly.
- <number> जुलाइ 28, 2014 There are three main objectives for this session. Firstly, we will review the general issues that arise when considering contract manufacture or analysis. Secondly, we will look at the responsibilities that the main parties to a contract have for the work to be done. Finally, we will talk about the contract itself and the key features that should be present.
- <number> जुलाइ 28, 2014 The main principle underlying contract production and analysis is very simple. The work has to be clearly defined, agreed and controlled to avoid misunderstandings. If misunderstandings arise, then work may be done which does not meet the quality standards set. The simplest way to avoid such misunderstandings is to have a written contract, setting out the duties of all parties to the contract and the standards that must be met. The standards of performance refer not only to product quality standards but also many other non-GMP aspects, e.g. relating to financial matters. It must be clear to everyone who is the authorized person, having the responsibility and the final authority to release a batch for sale. The authorized person must be involved in setting up the contract and agree to the way in which information will be provided that will allow him/her to make a decision to release a batch of product.
- <number> जुलाइ 28, 2014 Let us now look in more detail at the responsibilities of the contract giver. First of all, the contract giver is responsible for assessing the competence of proposed contract accepters that they will be able to do the work. The contract giver will normally know the product better than anyone else. This will be the case if the contract giver has developed the product. It knows the work that needs to be done. It must assess whether the companies that offer to do the work really have the capability to do it. This evaluation must also include an assessment as to whether they are able to operate in accordance with the GMP principles described in the WHO GMP text. Once the conclusion has been reached that the contract accepter has not only the technical competence but also the GMP competence, then the contract giver must provide a full package of technical information to the contract accepter. This should enable the contract accepter to make the product safely and in accordance with the marketing authorization. This means that all the information relevant to personnel, premises and equipment must be provided. If there are hazards associated with cross-contamination of other products these must be highlighted. Finally, the product made or tested under the contract must only be released by the authorized person in compliance with the marketing authorization. In some cases the authorized person may be a designated staff member of the contract accepter if this responsibility is delegated in writing by the contract giver and if such delegation is permitted by national regulations.
- <number> जुलाइ 28, 2014 Let us now look in more detail at the responsibilities of the contract giver. First of all, the contract giver is responsible for assessing the competence of proposed contract accepters that they will be able to do the work. The contract giver will normally know the product better than anyone else. This will be the case if the contract giver has developed the product. It knows the work that needs to be done. It must assess whether the companies that offer to do the work really have the capability to do it. This evaluation must also include an assessment as to whether they are able to operate in accordance with the GMP principles described in the WHO GMP text. Once the conclusion has been reached that the contract accepter has not only the technical competence but also the GMP competence, then the contract giver must provide a full package of technical information to the contract accepter. This should enable the contract accepter to make the product safely and in accordance with the marketing authorization. This means that all the information relevant to personnel, premises and equipment must be provided. If there are hazards associated with cross-contamination of other products these must be highlighted. Finally, the product made or tested under the contract must only be released by the authorized person in compliance with the marketing authorization. In some cases the authorized person may be a designated staff member of the contract accepter if this responsibility is delegated in writing by the contract giver and if such delegation is permitted by national regulations.
- <number> जुलाइ 28, 2014 The contract accepter also has responsibilities. The company must be competent to do the work. It means that it has the necessary facilities, premises and equipment, both in type and in quantity, to undertake the work. It must have a manufacturing authorization to do this type of work. This means that its staff has the necessary qualifications, training and experience to be able to do the work
- <number> जुलाइ 28, 2014 The contract accepter may not pass the work or any part of it on to a (third) subcontractor party without the approval of the contract giver. In order for the contract giver to be able to accept a third party, it must be able to undertake all the audits that it needs to be reassured that the third party is competent. All the responsibilities placed upon the contract accepter must be fulfilled by any third party contractor that may be employed. Finally, once a contract accepter has signed the contract, it must not then undertake new work which might adversely affect the quality of the existing products. An illustration of this would be to take on manufacture a penicillin product in the same facility, as other products of the contract giver.
- <number> जुलाइ 28, 2014 The contract that is prepared between the contract giver and the contract accepter must identify clearly the responsibilities each has with respect to the relevant sections, and the work to be done. All the technical details and specifications must be prepared by competent technical staff. All the arrangements must be in accordance with the marketing authorizations and agreed by both giver and accepter. The contract must be very clear about the way in which the authorized person will approve the product for sale. It must enable the authorized person to check that each batch has been made in compliance with the marketing authorization. The contract must specify who is responsible for the purchase and testing of all incoming materials and their release to production. It must also specify all the in-process testing that is to be done and who is responsible for sampling and analysis. In the case of contract analysis, the contract should specify whether the contract accepter is responsible for sampling, and if so where the sampling is to be done. If contract analysis is being undertaken then the contract must show how the information will be processed and in what time span it will be done.
- <number> जुलाइ 28, 2014 The contract that is prepared between the contract giver and the contract accepter must identify clearly the responsibilities each has with respect to the relevant sections, and the work to be done. All the technical details and specifications must be prepared by competent technical staff. All the arrangements must be in accordance with the marketing authorizations and agreed by both giver and accepter. The contract must be very clear about the way in which the authorized person will approve the product for sale. It must enable the authorized person to check that each batch has been made in compliance with the marketing authorization. The contract must specify who is responsible for the purchase and testing of all incoming materials and their release to production. It must also specify all the in-process testing that is to be done and who is responsible for sampling and analysis. In the case of contract analysis, the contract should specify whether the contract accepter is responsible for sampling, and if so where the sampling is to be done. If contract analysis is being undertaken then the contract must show how the information will be processed and in what time span it will be done.
- <number> जुलाइ 28, 2014 All manufacturing, analytical and distribution records and reference standards or retention samples must be kept by or be made available to the contract giver. Any records relevant to assessing the quality of a product in the event of a complaint or a suspected defect must be accessible to the contract giver. These records must also be specified in the defect/recall handling procedures used by the contract giver. This is to ensure that in the event of the need to recall a product, the contract giver can immediately access necessary records. The contract should also specify clearly what would happen to materials that are rejected.
- <number> जुलाइ 28, 2014 In your groups we would like you to use your own experience and knowledge to identify the key items that should appear in a contract. You have a maximum of 30 minutes, and we will be looking for 10-minute feedback in the plenary session from each group. Please don’t forget to designate your chairperson and reporter quickly. Also use the brainstorming technique to identify the issues that you are going to work with.
- <number> जुलाइ 28, 2014 Here are some issues that you may have experienced. Owners of companies may decide where a product may be made. These facilities may be unsuitable for a variety of reasons. Holders of the marketing authorization may come under a lot of pressure when looking for a new facility to use the facilities of a relative or a friend of the owner. In doing so they may wish to overlook defects in the facility. Owing to the sudden breakdown of a machine, a company may be in a rush to move production to a new facility or machine and there is no time to complete the validation work that is needed. A facility is accepted for contract manufacture on the basis of an existing range of products made there but it later accepts a new product into its range that conflicts with the contract product. What can be done? First of all the contract should state that in such a situation the contract giver has the right to remove its product immediately from that facility without a claim for loss. The contract giver may wish to include a penalty clause against this happening. It may also wish to include a clause requiring the contract acceptor to notify the contract giver if any new products taken on.
- <number> जुलाइ 28, 2014 The contract acceptor does not have all the equipment in the contract specified. This may be overcome by validation work. The contract giver should check that the contract accepter is using the correct equipment. Clauses should have been included in the contract to cover the eventuality. If the contract accepter does not follow the agreed procedures, it should be penalized exactly the same as if it uses inappropriate equipment.
- <number> जुलाइ 28, 2014 The contract giver should check that the contract accepter is making the product in accordance with all the product registration details. Changing sources of starting materials without notification will be in contravention of GMP. The contract giver has updated the specifications without notifying the contract accepter. The inspectors form the national authority should check for all relevant SOPs and documentation regarding contract production and analysis.