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SOP of Signature Log | Pharmaceutical Industry

1. Purpose :  To lay down the procedure for signature log. 2.Scope :  This procedure is applicable to all employees working in a company...

SOP ON SOP (HOW TO PREPARE SOP) – PHARMACEUTICAL INDUSTRY

1.Objective To lay down procedure for preparation, review, approval, issuance & retrieval of Standard Operating Procedure. (SOP) 2.Scope This procedure is applicable to preparation of SOP for all the cGMP activities. 3.Responsibilities User Dept. QA Dept. 4.Procedure: The procedure is described further into sub parts. i.e....

SOP for Product Recall in Pharmaceutical Industry

1. Objective To lay down a procedure for product recall. 2. Scope This procedure applies to the recall of a batch or batches of any product for which the company is licenced holder, authorised distributor or importer 3....

SOP for Performance Qualification of LAF, RLAF and Dynamic Pass Box

    1. Objective: To lay down a procedure for performance qualification of LAF, RLAF and dynamic pass box. Scope: This procedure is applicable for performance qualification of LAF, RLAF and dynamic pass box Installed...

SOP for Cleaning and Sterilization of Bulk Storage Tank

1. Objective: To lay down a procedure for cleaning and sterilization of bulk storage tank during batch to batch and product to product cleaning. Scope: This procedure is applicable for cleaning and sterilization of bulk...

Validation Master Plan for Pharmaceutical Industry

Author of the document Prepared by         Designation: Signature Date: Reviewer of the document for correctness Reviewed by:         Designation: Signature: Date: Approver of the document for use Approved by: Designation: Signature: Date:         Table of contents: 1. Validation policy 2. Scope 3. Responsibility 3.1 Production department 3.2 Quality control department 3.3 Engineering department 3.4 Quality assurance department 4. Site...

SOP for Microbiological Analysis of Water

1. Objective To lay down a procedure for microbiological analysis of water. 2. Scope This procedure is applicable for analysis of potable, purified and distilled water. 3. Responsibility Microbiology department 4. Procedure 4.1 Limits: Total viable count: Grade of Water Alert Limit   Action Limit   Target...

SOP for Preventive Maintenance of Production Equipment, Laboratory Instruments and Utilities in Pharmaceuticals

1. Objective: To lay down a procedure for preventive maintenance of production equipment, laboratory instruments and utilities. 2. Scope: This procedure is applicable for preventive maintenance of production equipment, laboratory instruments and utilities. 3. Responsibility Engineering department 4. Procedure: 4.1 Frequency and...

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