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…
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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Question & Answer on Quality Control Part -III AS PER EU Guidelines (EudraLex) Question: What is the purpose of the ongoing stability programme for medicinal products according to the EU GMP? Answer: The purpose of the ongoing stability programme is to monitor the product over its shelf life and ensure that it remains, and can…
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Question & Answer on Quality Control Part II AS PER EU Guidelines (EudraLex) Question: What validation is required for testing methods according to the EU GMP? Answer: Testing methods should be validated. If a laboratory is using a testing method for which it did not perform the original validation, it should verify the appropriateness of…
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Operation & cleaning of Non-viable Particle counter PURPOSE To lay down the procedure for operation & cleaning of non-viable particle counter. SCOPE This procedure is applicable for operation & cleaning of non-viable particle counter for SVP. REFERENCE(S) & ATTACHMENTS References WHO-TRS 961 guideline DIN EN ISO 14644-1 guidelines Attachments Attachment I : Instrument (Air born…
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Entry & Exit procedure for manufacturing room of SVP section PURPOSE: To lay down the written procedure for entry & exit for Clean area Manufacturing. SCOPE : This SOP is applicable for authorized staff & visitor’s movement in manufacturing area of SVP Section. REFERENCE(S) & ATTACHMENTS References In-House Attachments Attachment-I: Clean Area entry &…
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