SOP ON IMPACT ASSESSMENT FOR EQUIPMENT /SYSTEM OBJECTIVE: To assess the impact of process variables on quality of product prior to carrying out process validation. SCOPE: This SOP is applicable for different stages of manufacturing for product to be validated. RESPONSIBILITY: It is the responsibility of operator and production supervisors to follow the procedure as … Read more
SOP FOR HANDLING OF REPROCESSING AND REWORKING OBJECTIVE: To describe a procedure for reworking and reprocessing of the batch. SCOPE: This SOP is applicable for reworking and reprocessing of the batch. RESPONSIBILITY: Production Operator & Supervisor: Responsible for compliance the reprocessing of the batch with proper documentation. ACCOUNTABILITY: Head QA is accountable for the implementation … Read more
RISK ASSESSMENT PROTOCOL FOR DEPYROGENATION TUNNEL To establish documented evidence that the design of in–use “Vial Filling and rubber stoppering Machine” is in compliance with the GMP, Safety and Operational requirements identified in the Risk Assessment document. In the project content, risk analyses are performed as basic GMP/EHS-Risk Assessment, which shall help to identify important … Read more
Procedure-for-calibration-of-calculator-quality-assurance/Validation of digital Calculator Objective: The purpose of this SOP is to lay down a procedure for validation of digital calculator. Scope: This SOP is applicable to all digital calculator use in Quality Control Department. Responsibility: Chemist or above of QC laboratory. Accountability: Head – Quality Control. Procedure: Identification to Calculator: Calculators existing in department shall be identified by specific … Read more
SOP on Handling of Returned Goods Objective : To lay down the procedure for handling of returned goods from customer. Scope : This SOP is applicable for handling of returned goods in Formulation. Responsibility: Executive / Manager – Warehouse / Excise Executive / Manager – Quality Assurance. Executive / Manager – Quality Control. Executive / … Read more
SOP on Additional testing Objective: To lay down a procedure to carry out additional testing after necessary QA approval so as to avoid unwanted testing and analysis. Scope: This procedure is applicable to any additional testing required for confirmation or investigation. The additional testing may be required for finished products, Intermediate products, Raw Materials and Packing materials. … Read more
SOP For Preparation of User Requirement Specification (URS) Objective: To lay down a procedure for preparation, review and approval of user requirement specification. Scope: This procedure outlines the requirements which shall be followed when creating a User Requirement Specification (URS), which is referred to as system or equipment design documentation. This procedure applies to all systems … Read more
SOP on Validation Master Plan (VMP) Objective: To lay down a procedure for preparation of Validation Master Plan (VMP) for facility. Scope: This SOP describes the preparation of validation master plan for the facility, area, equipments, processes, instruments, utilities and analytical methods for Formulation plant. Responsibility: Officer/Executive-QA shall be responsible for preparation of Validation Master … Read more
SOP on function of quality assurance department Objective: To describe the guideline for the function of quality assurance department. Scope: This SOP applicable for the function of quality assurance department of the Formulation plant. Responsibility: Quality assurance department. Accountability: HEAD – QA shall accountable for compliance of SOP. Procedure: Ensures that:- Medicinal products are designed and developed in … Read more
SOP on job responsibilities of personnel working in Quality Assurance. Objective: To lay down the procedure for providing the job responsibilities of personnel working in quality assurance department. Scope: The scope of this SOP is limited to the Quality Assurance department at formulation plant. Responsibility: Head – Quality Assurance is responsible for assigning the job responsibilities … Read more