Pharmaguidances ENVIRONMENTAL MONITORING BY AIR SAMPLING METHOD OBJECTIVE: To lay down a procedure Environmental monitoring by Air sampling method. SCOPE: This SOP is applicable for Environmental monitoring by Air sampling method of this organization. RESPONSIBILITY: Quality control – Executives Quality control – Officer (microbiologist) ACCOUNTABILITY: Quality control – Head ABBREVIATIONS: SCDA: Soya bean Casein digest agar PRECAUTIONS: Before … Read more
Personal monitoring by contact plate method in sterility testing area. OBJECTIVE: To lay down a standard operating procedure for personal monitoring by contact plate method in sterility testing area. SCOPE: This SOP is applicable for personal monitoring by contact plate method in sterility testing area. RESPONSIBILITY: Quality control – Executives Quality control – Officer (microbiologist) ACCOUNTABILITY: … Read more
SOP on container closure integrity for Dry powder for injection Objective : To lay down the procedure for container closure integrity for Dry powder for injection. Scope: This SOP is applicable for container closure integrity for Dry powder for injection. Responsibility: Officer or above of Microbiology Laboratory. Head – Microbiology section. Accountability: Head – Quality Control. Procedure: Chemical … 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
SOP on In-process checks during Dry powder injection manufacturing & packing. Objective: To lay down a procedure for in process checks during Dry powder injection manufacturing & packing. Scope: This procedure is applicable to formulation unit. Responsibility: IPQA Officer/Executive shall be responsible for preparation & execution of the SOP. Accountability : Head QA shall be accountable for … Read more