Supporting Clean Areas Supporting clean areas can have various classifications and functions. Many support areas function as zones in which…
Sterile Product Building, Facility and Clean Area Classification Guideline By USFDA has clearly mentioned what conditions to be followed to…
TEST FOR SPECIFIED MICRO-ORGANISMS (Ph. Eur. method 2.6.13.) INTRODUCTION The tests described hereafter will allow determination of the absence or…
The purpose of this Standard Operating Procedure (SOP) is to lay down the procedure for Operation, maintenance and Calibration of…
21 CFR 211.42(b) states, in part, that “The flow of components, drug product containers, closures, labeling, in-process materials, and drug…
Project Phase Validation4.1 The validation documentation and reports should cover the relevant steps of the life cycle. Manufacturers should be…
PrincipleThis annex applies to all forms of computerised systems used as part of a GMP regulated activities. A computerised system…
PrincipleLiquids, creams and ointments may be particularly susceptible to microbial and othercontamination during manufacture. Therefore special measures must be taken…
PrincipleSampling is an important operation in which only a small fraction of a batch is taken. Valid conclusions on the…
EU Guidelines For Outsourced Activities Any activity covered by the GMP Guide that is outsourced should be appropriately defined, agreed…