SOP on Product Recall and Handling of Recalled Products Objective : To lay down a procedure for product recall and handling of recalled products Scope : This Standard Operating Procedure is applicable for recall of drug products and handling of recalled drug products manufactured or marketed. Responsibility : Head, Quality Assurance/ designee shall be responsible for the … Read more
SOP on Handling of Product Complaints Objective : To lay down a procedure to investigate, document and respond to the product complaints. Scope : This Standard Operating Procedure shall be applicable to all pharmaceutical drug products (formulations) manufactured or marketed. Responsibility Head, Marketing of the concerned division shall be responsible for forwarding the complaints received from sales … Read more
Internal Audit and Self Inspection Objective : To lay down a procedure for periodic internal audit and self inspection, to ensure current Good Manufacturing Practices compliance. Scope : This Standard Operating Procedure is applicable to all departments of all formulation plants of Panacea Biotec Limited. Responsibility : Audit Team : Auditing the facility and to prepare audit … Read more
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