shivpharma2016

Procedure-for-calibration/Validation of digital Calculator

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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

ENVIRONMENTAL MONITORING BY SETTLE PLATE METHOD

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ENVIRONMENTAL MONITORING BY SETTLE PLATE METHOD OBJECTIVE: To lay down a procedure Environmental monitoring by settle plate method. SCOPE: This SOP is applicable for Environmental monitoring by settle plate method of this organization. RESPONSIBILITY: Quality control – Executives Quality control – Officer (microbiologist) ACCOUNTABILITY: Quality control – Head PRECAUTIONS : Glass wares employed for sampling should be … Read more

ENVIRONMENTAL MONITORING BY AIR SAMPLING METHOD

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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.

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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

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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

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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

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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)

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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)

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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.

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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