| Good Documentation Practices (GDP) |
1.0 OBJECTIVE To lay down the procedure for good documentation practices for GxP documents (electronic records and manually generated records). 2.0 SCOPE This procedure is applicable for good documentation practices for all documents applicable in order to ensure uniformity of the documentation practices throughout the organization for proper implementation of quality. 3.0 RESPONSIBILITY • Officer or above of concerned department shall be responsible for implementation of this SOP. • All concerned department Heads / Executive or above of user & Quality Assurance shall be responsible for review of documents for their compliance. 4.0 ACCOUNTABILITY • Department Head • Head Quality / QA To Read this SOP Click here SOP for Handling of Deviation. 5.0 PROCEDURE 5.1 Definition 5.1.1 Document: A written or printed paper containing original complete and consistent information. Document include but not limited to: Standard operating procedure (SOP), Bath processing records, Equipment cleaning records, specification and standard test procedure (STP) / General test procedure (GTP) protocol etc.. 5.1.2 Documentation: Documentation is an essential part of quality assurance system and such, shall be relate to al Good manufacturing practices (GMP). Its aim to define the specifications for all material, method of manufacturing and control, to ensure that all personnel concerned with manufacture know the information necessary to decide whether or not to release a batch of drug for sale and to provide and audit trial that shall permit investigation of the history of any suspected defective batch in quality assurance department. 5.1.3 Good Documentation Practices (GDP):A systematic procedure of preparing, reviewing, approving, issuing, recording, storage and archival of documents associated with GxP activities. 5.1.4 Good Manufacturing Practices (GMP): GMP are the practices required in order to confirm to guidelines recommended by agencies that control authorization and licensing for manufacture and sale of drug substances /active pharmaceutical ingredients. 5.1.5 GMP Documents: GMP documents are define as all records which directly or indirectly, individually or collectively control the strength, identity, safety, purity and quality of drug substances in quality assurance. 5.1.6 GxP: This term itself encircles many different regulations in many different fields. The G for “Good” and “P” for Practice”. The “x” in the middle is a variable that can be substituted with any words that appropriately complete the definition of field of manufacturing facility. |
