1. Introduction 2. Number of Intermediates and APIs batches produced. 3. Review of out put for all Isolated Intermediates and Finished Products. 4. Review of Critical Quality attributes of In-process, Isolated Intermediates and Finished Products. 5. Summary of changes made during the year with respect ...

The element of ALCOA is follows, A – Attributable to the person generating the data L- Legible and permanent C – Contemporaneous O – Original record (or ‘true copy’) A – Accurate Attributable: The identity of the person completing a record should be unambiguous. The use of ...

1. Clear and concise titles should be used for headings, tables, graphs, etc. 2. Pages in the master document should be numbered as X of Y. 3. Full-text spelling with the abbreviation in brackets should be used for the first time. The abbreviation may be used in place of full-text spelling in the remainder ...

A batch manufacturing record is a written document from the batch that is prepared during the pharmaceutical manufacturing process. It contains step-by-step batch production and actual information of the entire production process. There are several steps in the pharmaceutical product manufacturing process. ...

Method transfer, is the documented process that qualifies a laboratory (the receiving unit) to use an analytical test procedure that originated in another laboratory (the transferring unit), thus ensuring that the receiving unit has the procedural knowledge and ability to perform the transferring analytical ...

GxP in pharmaceuticals stands permanently Practice; it ensures the standard and effectiveness of product for drugs, food, medical instrumentality, and alternative life-serving product as per restrictive standards. GxP is an element of fine follow as a result of its associated with the producing of life-saving ...

The pharmaceutical industry is one of the fastest growing and sensitive sectors dealing with medicine, patients, medicinal drugs and pharmacists. It needs to be handled carefully to avoid risk to people at risk. Thus rules and regulations governing operations within the pharmaceutical industry are set ...

One of the biggest concerns that the pharmaceutical industry constantly tries to address is the safety of its products. GxP is a set of regulations that aim to address this issue in a systematic and healthy way. The concept of GxP requirements in pharmaceuticals was established by the US Food and Drug ...

One of the biggest concerns that the pharmaceutical industry constantly tries to address is the safety of its products. GxP is a set of regulations that aim to address this issue in a systematic and healthy way. The concept of GxP requirements in pharmaceuticals was established by the US Food and Drug ...

1. Incorrect entries in GMP records should not be overwritten or blocked to make it unreadable. Always use a single strike outline (For example Incorrect Entry) to mark the incorrect entry in such a manner that entry remains readable. 2. Correct entry should be written near to the strikeout entry. Person ...