January 19, 2021 - Pharmaceutical Guidelines

EU Guidelines For Computerized System Part- 2

Project Phase Validation4.1 The validation documentation and reports should cover the relevant steps of the life cycle. Manufacturers should be able to justify their standards, protocols, acceptance criteria, procedures and records based on their risk assessment. 4.2 Validation documentation should include change control records (if applicable) and reports on any deviations observed during the validation […]

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EU Guidelines For Computerized System Part -1

Quality Assurance

PrincipleThis annex applies to all forms of computerised systems used as part of a GMP regulated activities. A computerised system is a set of software and hardware components which together fulfill certain functionalities.The application should be validated; IT infrastructure should be qualified.Where a computerised system replaces a manual operation, there should be no resultant decrease

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Manufacture of Liquids, Creams and Ointments

Production

PrincipleLiquids, creams and ointments may be particularly susceptible to microbial and othercontamination during manufacture. Therefore special measures must be taken to prevent any contamination. Premises and equipment The use of closed systems for processing and transfer is recommended in order to protect the product from contamination. Production areas where the products or open clean containers

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Sampling on Starting and Packaging Materials

Packaging

PrincipleSampling is an important operation in which only a small fraction of a batch is taken. Valid conclusions on the whole cannot be based on tests which have been carried out on non representative samples. Correct sampling is thus an essential part of a system of Quality Assurance.NoteSampling is dealt with in Chapter 6 of

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EU Guideline For Outsourced Activities

Quality Assurance

EU Guidelines For Outsourced Activities Any activity covered by the GMP Guide that is outsourced should be appropriately defined, agreed and controlled in order to avoid misunderstandings which could result in a product or operation of unsatisfactory quality. There must be a written Contract between the Contract Giver and the Contract Acceptor which clearly establishes

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