OBJECTIVE : To lay down the procedure for Installation, Operation and Performance qualification of Equipment. RESPONSIBILITY : Validation team comprising of representatives from functional department, Engineering department and Quality Assurance department. Head – QA, Head – Engineering and Head of the concerned department to ensure compliance. PROCEDURE Any …
Read More »Preparation, Approval and Control of Standard Cleaning Procedures for equipments
Preparation, Approval and Control of Standard Cleaning Procedures for equipments OBJECTIVE : To lay down the guidelines for the preparation, approval and control of Standard Cleaning Procedure (SCP) for all the applicable equipments. RESPONSIBILITY : All the personnel involved in the cleaning of equipments. Heads of concerned departments to ensure …
Read More »SOP On Document and Data Control
SOP On Document and Data Control Objective: To lay down a procedure for control of documents and documented data. Scope: This Standard Operating Procedure is applicable for the control of documents and documented data at the formulation plant of Pharmaceuticals Company Name with Location. Responsibility All HODs shall be responsible …
Read More »SOP ON SOP (Standard Operating Procedures)
Preparation, Approval, Review and Control of Standard Operating Procedures Standard Operating Procedure (SOP) is a document where step by step instructions are cited to serve as support for methods or manners of fulfilling a function or functions reliably and consistently. Standard operating procedures will be present everywhere within your organization …
Read More »Process Validation: General Principles and Practices (January 2011)
Process Validation The concept of the product lifecycle connects the development of the product and the manufacturing process, the qualification of the commercial manufacturing process, and the maintenance of the process to ensure control during routine production. This guidance promotes scientific principles to support process improvement and innovation. This guidance …
Read More »Stability Testing
STABILITY STUDY
STABILITY STUDY MANAGEMENT To lay down the procedure to conduct stability studies of the drug product (dosage forms)/ Drug substances (API). This Document describes the procedure for assigning the stability of drug substances (Active pharma ingredients) and drug products (Packed finished dosage forms). The purpose of stability studies is to …
Read More »Preparation of Validation and Qualification Protocols
Preparation of Validation and Qualification Protocols Objective To lay down a procedure for Preparation of Validation and Qualification protocols applicable to all aspects of manufacturing processes, equipments, control systems (including computer hardware and software), utilities, facility, temperature mapping, Shipping and any significant changes to the above mentioned elements which may …
Read More »Pharmaceuticals Facility and cGMP Expectations
Current Good Manufacturing Practices in Pharmaceutical Industry The cGMP requirements are described in the various guidelines which deal mainly in the following categories, e.g., (A) Requirements related to surroundings. (B) General requirements for pharmaceutical plants. (C) Requirements related to various departmental areas in the plant and (D) Requirements related to …
Read More »SOP on Quality Risk Management
Objective To describe the procedure for management of risks, arising from different operations, activities and discrepancies. Scope This SOP shall cover overall management of risks that arise from different operations, activities, discrepancies, deviations and failures in the manufacturing operations of Pharmaceutical company. Responsibility Each Operating Manager and the Department Head …
Read More »SOP on Acceptable Quality Level (AQL) During Product Inspection for physical defects.
SOP on Acceptable Quality Level (AQL) During Product Inspection for physical defects. ” Product Inspection for Physical defects ” shall be filed in the Batch Production Record of the respective drug product In case the incidence of recurrence of a particular defect is frequent , for consecutive batches, Officer – QA shall …
Read More »SOP on Artwork Design and Approval
SOP on Artwork Design and Approval Objective: To lay down a procedure for artwork design and approval (of Printed packaging materials). Scope: This Standard Operating Procedure is applicable to all drug products manufactured and marketed by Pharmaceutical company. Responsibility: For Artwork development and approval system of Export markets Head Marketing …
Read More »SOP on writing & approval of Qualification and validation protocol & reports
SOP on writing & approval of Qualification and validation protocol & reports Objective: To describe the procedure for writing & approval of qualification and validation protocols & reports. Scope: This SOP is applicable to all type of qualification and validation protocol & report for all department to Formulation plant of …
Read More »SOP on Maintaining of Equipment Log Book
SOP on Maintaining of Equipment Log Book Objective: To lay down a procedure for maintaining of equipment log book. Scope:T his Standard Operating Procedure is applicable for maintaining of equipment log book associated with product (s) manufactured at formulation plant. Responsibility All the concerned personnel shall be responsible to follow …
Read More »SOP On Issuance and Submission of Batch Manufacturing Record (BMR)
SOP On Issuance and Submission of Batch Manufacturing Record (BMR) Objective: To lay down the procedure for issuance and submission of batch manufacturing record (BMR). Scope: This SOP shall be applicable for issuance and submission of batch manufacturing record (BMR) to Production in Formulation plant.. Responsibility Production personnel shall be …
Read More »SOP on Recording of Specimen Signature
SOP on Recording of Specimen Signature Objective: To lay down the procedure to record the specimen signature. Scope: This Standard Operating Procedure is applicable for recording of specimen signature of all the personnel working at Pharmaceutical Company. Responsibility Concerned personnel of all department shall be responsible for following the procedure …
Read More »Preparation, Approval, Review and Control of MFC and MPC for Manufacture of Pharmaceutical Products
Preparation, Approval, Review and Control of MFC and MPC for Manufacture of Pharmaceutical Products Objective: To lay down a procedure for the Preparation, Approval, Review and Control of MFC for Manufacture of Pharmaceutical Products. Scope: This Standard Operating Procedure is applicable for preparation and implementation of MFR for all products …
Read More »CALIBRATION PROCEDURE FOR HALOGEN MOISTURE ANALYSER
CALIBRATION PROCEDURE FOR HALOGEN MOISTURE ANALYSER OBJECTIVE: To lay down the procedure for calibration of Halogen moisture analyzer, Make- Metler – Toledo. SCOPE: This SOP shall provide the calibration procedure of Halogen moisture analyzer in in-process quality assurance department and quality control department. RESPONSIBILITY : Officer/ Executive – Quality Control/Quality Assurance. …
Read More »Collection, Storage and Control of Control Samples for Drug Products
OBJECTIVE :To lay down a procedure for collection, storage, retrieval and disposition of Control samples of drug products. RESPONSIBILITY :Quality Assurance Officer for collection, storage, retrieval and disposal of Control samples. Head of Quality Assurance Department to ensure compliance. PROCEDURE :Every batch/lot of each drug product in all forms of its …
Read More »Responsibilities of Quality Assurance Department
Responsibilities of Quality Assurance Department OBJECTIVE: To lay down the responsibilities of the Quality Assurance Department. RESPONSIBILITY : All personnel of the Quality Assurance Department. Head of Quality Assurance Department to ensure compliance. PROCEDURE : The Quality Assurance department shall be responsible to formulate systems for the implementation of cGMP …
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