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21 CFR Part 11 OR Code of Federal Regulations.

21 CFR Part 11 ( Code of Federal Regulation ) What is 21 CFR?   It is code of federal regulation. It is a codification of the general and chronic rules published in the Federal Register by the head department and agency of the federal government. Title 21 of the CFR is reserved for rules of the Food and Drug Administration called FDA. It is a part of title 21 CFR that organized the United States FDA law on electronic records and electronic signatures.   Part 11 is defines the criteria under which electronic records and electronic signatures are considered trustworthy reliable and equivalent to paper records. Records are kept for a number of reasons.   It happens only to those records “that persons create, modify, maintain, archive, or transmit under any records or signature requirements set forth in the federal Food, Drug, and Cosmetic Act or any FDA regulations”. Traditionally these records have been paper-based and stored in files or binders   When those reco

Handling of deviation

Handling of deviation  Deviation: Aviation are measured difference between observed value and expected or normal value for a process or product condition. Why deviation occurs:      GMP Mistakes or Error Performing an activity without proper training. Failure due to not following written SOPs,STP or approved batch record instruction. Reprocessing or rework. Unapproved changes. Type of deviation:   There are two type of deviation which is explained as: Planned deviation Unplanned deviation Planned deviation: Planned deviation, which are described, and pre approved deviation from the current operational document/system, covering a specified period of time or number of batches. All changes should be evaluated for quality of product and yield of products. The need for qualification or re-validation . Change ultimately approved are rejected by quality assurance. For quality improvement of products. Use new instrument or new method parameter. Maintena