GOOD DOCUMENTATION PRACTICES PURPOSE : To lay down a procedure for good documentation practices requirements for the compliant, consistent and accurate completion of GxP Documentation. SCOPE : This SOP applies to all cGxP documents (electronic and handwritten) used in the manufacturing, packaging, labelling, testing, storage and distribution of Drug Products and Drug Substances for commercial. It also … Read more

TRAINING PROGRAMME AND MANAGEMENT PURPOSE : To lay down a procedure to conduct training of working personnel at all levels and its evaluation. SCOPE : This SOP shall be applicable for all employees working in this company. REFERENCE (S) : A WHO guide to good manufacturing practice (GMP) requirements. ASEAN-TMHS-GMP-Training-Chapter-5-Documentation. PIC/S PE 009-14 CROSS REFERENCE … Read more

SOP ON SOP (Preparation, Approval and Control of Standard Operating Procedures) Objective : To lay down a procedure for the preparation, approval and control of Standard Operating Procedures. Scope : This Standard Operating Procedure is applicable for the preparation and implementation of all Standard Operating Procedures to be followed at pharmaceutical Research and Development and all … Read more

DOCUMENT(S) AND DATA CONTROL PROCEDURE PURPOSE : To lay down a procedure for control of documents, documented data and records. SCOPE : This Standard Operating Procedure is applicable for the control of documents and documented data and records. REFERENCE(S) Chapter-4: Documentation (EudraLex Volume4 GMP medicinal products for Human & Veterinary use.) A WHO guide to … Read more

PROCEDURE FOR INVESTIGATION OF OUT OF TREND RESULTS (OOT) PURPOSE : To lay down a procedure for investigation and evaluation of Out of Trend results, obtained during the release testing and stability study analysis. SCOPE : This SOP is applicable to for investigation and evaluation of Out of Trend results, obtained during the release testing of … Read more

SOP ON HANDLING OF OUT OF SPECIFICATION (OOS) PURPOSE To establish a procedure for evaluation and handling of ‘Out of specification (OOS)’ test results identified by Quality Control department. SCOPE This SOP covers procedure involved in investigation of out-of-specification (OOS) results pertaining to Starting materials, Packaging materials, finished products, in process samples and stability samples, … Read more

SOP ON INVESTIGATIONS PURPOSE This Standard Operating Procedure (SOP) defines the requirements for reporting, documenting, investigating, evaluating, managing, resolving and approving closure of investigations from cGxPs, approved specifications and/or procedures. SCOPE This standard applies to Investigations related to quality related events that occur from cGxPs, approved specifications, and/or procedures including but not limited to Protocols, … Read more

Deviation Control OBJECTIVE: To lay down the procedure to describe the steps to be followed in case of planned/unplanned deviation from the standardized activity, or standard procedure. PROCEDURE : Deviations are of two types: Planned & Unplanned. Planned Deviation: Any Deviation in the procedure, process, equipment, or standard batch size which is planned, documented, assessed … Read more

OBJECTIVE: To lay down the procedure for Change Control System. PROCEDURE: If anybody wants to make a change in the existing system and feels that the change will be fruitful in terms of productivity, and quality; he/she should discuss it with his / her department head. If the department head feels that it is required, … Read more

Product Quality Review OBJECTIVE: To lay down the Procedure for preparation of Product Quality Review. PROCEDURE : Product Quality Review (PQR) is a mechanism to ensure that data captured by the Pharmaceutical Quality System (PQS) is reviewed for trends. This tool can support a continuous improvement environment. PQRs are designed for the purpose of identifying and … Read more