Checking of the vehicle before loading finished goods OBJECTIVE To lay down a procedure and checklist for inspection of the vehicle(s) engaged in the transportation of finished goods, before loading at the warehouse of the manufacturing site begins. PROCEDURE The vehicle may be owned or a hired vehicle from authorized transporters. On receiving vehicle(s) for…
MANAGEMENT OF ASEPTIC AREA AFTER POWER RESUMES PURPOSE: To establish a written procedure for the management of the filling area after power resumes. SCOPE: This SOP shall be applicable for the management of filling area after power resumes. REFERENCE(S) : WHO-TRS 961 (annexure: 1) & FDA and schedule M CROSS-REFERENCE DOCUMENTS Document(s) and Data Control Procedure Training…
URS for the Replacement Old Sachet Filling & Sealing Machine with New Filling & Sealing Machine for ORS Section TABLE OF CONTENTS: Approval Table of contents Objective Scope Purpose Reference Guidelines Contractual Status Abbreviations System Description Process Description Technical Data Building Construction Manufacturing Equipment Risk factors Required document Objective To define the instruction and requirements…
DOCUMENT(S) AND DATA CONTROL PROCEDURE PURPOSE To lay down a procedure for control of documents, documented data and records. SCOPE This Standard Operating Procedure is applicable for the control of documents and documented data and records. REFERENCE(S) & ATTACHMENT(S) REFERENCE(S) Chapter-4: Documentation (EudraLex Volume4 GMP medicinal products for Human & Veterinary use.) A WHO guide…
SOP ON SOP PURPOSE To lay down a standard procedure for the preparation, approval, authorization and control of Standard Operating Procedures. SCOPE This Standard Operating Procedure is applicable for the preparation, approval, control and implementation of all Standard Operating Procedures of all departments and it is to be followed All the SOP that will be…
Management of sterile area after power resume PURPOSE : To describe the procedure for management of sterile area after power resume. SCOPE : This SOP will be applicable for resuming of sterile area after power failure at sterile area of SVP section RESPONSIBILITY Operator: To follow all the instructions described here in. Production Person/Designee: To verify…
MONITORING OF NON-VIABLE PARTICLE COUNT IN CLASSIFIED AREA OF SVP SECTION PURPOSE To establish the written procedure for monitoring of non-viable particle count in classified Area SVP section. SCOPE This SOP shall be applicable for monitoring of non-viable particle count in classified area of SVP section REFERENCE(S) & ATTACHMENT(S) REFERENCE(S) WHO-TRS 961 guideline FDA and schedule M…
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Operation, cleaning & precaution of three bucket system PURPOSE : To lay down the procedure for operation, cleaning & precaution of three bucket system. SCOPE : This procedure is applicable for operation, cleaning & precaution of three bucket system used for mopping &…
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CLEANING, OPERATION, PRECAUTIONS & MONITORING OF AUTOMATIC STICKER LABELING MACHINE PURPOSE : To provide written procedure for cleaning, operation, precaution & monitoring of automatic sticker labeling machine. SCOPE : This SOP shall be applicable for cleaning, operation, and precaution & monitoring of automatic sticker labeling machine at SVP section. REFERENCE(S) Operating Instructions manual of labeling machine…
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Cleaning, Operation & monitoring of Vacuum leak test machine PURPOSE To lay down the procedure for cleaning, operation & monitoring of vacuum leak test Machine. SCOPE This SOP is applicable for cleaning, operation & monitoring of vacuum leak test machine at SVP manufacturing facility Vacuum Leak Test Machine REFERENCE(S) & ATTACHMENTS References User manual…
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Cleaning, operation, monitoring & Mould change procedure of FFS machine PURPOSE: To lay down the procedure of Cleaning, operation, monitoring & Mould change procedure of FFS machine. SCOPE : This SOP is applicable for Cleaning, operation, monitoring & Mould change procedure of FFS machine at WFI manufacturing facility. REFERENCE(S) & ATTACHMENTS: References FFS machine user manual…
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IN-PROCESS CHECK DURING VARIOUS MANUFACTURING STAGES IN SVP SECTION PURPOSE To define the procedure for in-process check during various manufacturing stages in SVP Section. SCOPE This SOP covers the in-process check procedure during various manufacturing stages of SVP Section CROSS REFERENCE DOCUMENTS Monitoring of temperature/humidity, differential pressure Monitoring of non-viable particle count in classified area of…
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Cleaning & sanitization of classified/clean area PURPOSE: To lay down the procedure for sanitizing the clean rooms in normal operation and during various interruptions to make the clean area free from microbial & particle load. SCOPE: This SOP will be applicable for cleaning & sanitization of classified clean area manufacturing, filling, air lock system, autoclave room of…
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CLEANING, OPERATION, MONITORING & PRECAUTIONS OF HPHV STEAM STERILIZER PURPOSE : To lay down the procedure for cleaning, operation, monitoring & precautions of HPHV steam sterilizer. SCOPE : This SOP is applicable for HPHV steam Sterilizer of SVP Section HPHV steam sterilizer -Machine Fabric -Unit Preparation Room REFERENCE(S) WHO-GMP guide lines & Operating Manual of garment autoclave…
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CLEANING, OPERATION, PRECAUTION, MAINTENANCE & CALIBRATION OF pH METER PURPOSE : To establish written procedure for cleaning, operation, precaution, maintenance & calibration of pH meter. SCOPE : This SOP shall be applicable for cleaning, operation, precaution, maintenance & calibration of pH meter at SVP section REFERENCE(S) User Manual of pH meter CROSS REFERENCE DOCUMENTS Document(s) and Data Control…
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SOP FOR RESUMING OF ASEPTIC AREA AFTER MAINTENANCE ACTIVITIES PURPOSE : To provide written procedure for resuming of aseptic area after maintenance activities. SCOPE : This SOP shall be applicable for resuming of aseptic area after maintenance activities at SVP section. REFERENCE(S) FDA and schedule M CROSS REFERENCE DOCUMENTS Document(s) and Data Control Procedure Training Program for…
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Operation and calibration of UV cabinet PURPOSE : To provide a procedure for operation and calibration of UV Cabinet. SCOPE : This SOP is applicable for quality control department for operation and calibration of UV Cabinet. References : Indian Pharmacopeia and In – house Attachments: Attachment-I : Calibration Record of UV Cabinet. RESPONSIBILITY Analyst / QC…
Cleaning, Operation & monitoring of Vacuum leak test machine PURPOSE: To lay down the procedure for cleaning, operation & monitoring of vacuum leak test Machine. SCOPE : This SOP is applicable for cleaning, operation & monitoring of vacuum leak test machine at SVP manufacturing facility References : User manual of Vacuum Leak Test Machine Attachments Attachment-I Vacuum…
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Operation & monitoring of Manufacturing Tank (1500 liters, 500 liters) & holding tank (300 liters) PURPOSE : To describe the procedure for operation & monitoring of manufacturing tanks (1500 liters,500 liters ) & holding tank (300 liters). SCOPE : This SOP is applicable for operation & monitoring of manufacturing tanks & holding tank at SVP manufacturing facility….
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Cleaning, Operation & monitoring of sticker labeling machine PURPOSE: To lay down the procedure for cleaning, operation & monitoring of sticker labeling machine. SCOPE : This SOP is applicable for cleaning, operation & monitoring of sticker labeling machine at WFI manufacturing facility REFERENCE(S) & ATTACHMENTS: References Sticker labeling machine user manual RESPONSIBILITY: Production Person: To verify that…
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