Pharmaguidances

SOP On Environment Monitoring (viable organisms) of Aseptic Processing areas Objective:  To lay down the procedure for Environment Monitoring (viable organisms) of Aseptic Processing areas. Scope: This SOP is applicable for Environment Monitoring (viable organisms) of aseptic processing areas . Responsibility: Microbiologist or above of Microbiology Laboratory. Head – Microbiology section. Accountability: Head – Quality … Read more

SOP on Stability studies of drug products Objective: To lay down a procedure for carrying out stability studies of drug products. Scope: This SOP is applicable for carrying out stability studies of drug products of Responsibility: QC Chemist or above Accountability: Head – Quality Control & Head – Quality Assurance Procedure: Stability study shall be … Read more

SOP ON HANDLING AND INVESTIGATION OF INCIDENT PURPOSE : To define the procedure for incident reporting and investigation. SCOPE : This guideline is applicable to, All incidents, which can affect the safety, identity, strength, purity and / or quality of the product which can be, Facility related. Storage related. Production related or occurred during processing. Raw / … Read more

SOP ON CORRECTIVE ACTION AND PREVENTIVE ACTION (CAPA) PURPOSE : This Standard operating Procedure (SOP) provides the requirements for identification, evaluation, implementation, effectiveness monitoring, closure and documentation of Corrective Actions and Preventive Actions (CAPA). The CAPA system is designed to address continuous improvement of Quality Systems. SCOPE : This procedure is applicable for all Corrective and Preventive … Read more

SOP ON DATA INTEGRITY AND DATA RELIABILITY PURPOSE : To describe the procedure for data integrity applies equally to manual (paper) and electronic data in all departments. SCOPE : This Standard Operating Procedure (SOP) shall be applicable for all activity performed either manually / electronic data entry in all departments of General Formulation Facility. REFERENCES MHRA GMP … Read more

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