Month: January 2021

Sterile Drug Products Produced by Aseptic Processing – USFDA Guideline for Buildings & Facilities

21 CFR 211.42(b) states, in part, that “The flow of components, drug product containers, closures, labeling, in-process materials, and drug products through the building or buildings shall be designed to prevent contamination.”21 CFR 211.42(c) states, in part, that “Operations shall be performed within specifically defined areas of adequate size. There shall be separate or defined …

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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

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

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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