Category: Small Volume Parenteral

Premises, Equipment & Finishing of sterile products as per WHO TRS 961-Annex 6  It is highly recommended that all premises are designed in a way that minimizes the unnecessary entry of supervisory or control personnel. Specifically, Grade A and B areas should be constructed in a manner that allows for complete observation of all operations…

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Operation, cleaning & calibration of pH meter 1.0       PURPOSE: To lay down the procedure for operation & calibration of pH meter. 2.0.      SCOPE :                                  This SOP shall be applicable for operation & calibration of pH meter of SVP manufacturing facility Equipment Name      Make &  Model No. Equipment ID pH meter 3.0       REFERENCE(S) & ATTACHMENT(S):…

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CLEANING, OPERATION, MONITORING & PRECAUTIONS OF MANUAL VISUAL INSPECTION TABLE & PROCESS FOR MANUAL INSPECTION OF SVP CONTAINERS.  1.0     PURPOSE To lay down the procedure for cleaning, operation, monitoring & precautions of visual Inspection table & process for manual visual inspection of filled & sealed SVP containers. 2.0     SCOPE                                                                                                             This SOP is applicable for…

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Cleanroom behavior & personal hygiene 1.0      PURPOSE: To describe the procedure for personal hygiene & behavioral approach during clean room operation. 2.0.     SCOPE :                                   This SOP will be applicable for behavioral approach & personal hygiene for all the Staff, operators & workers of clean area of SVP section 3.0       REFERENCE(S) & ATTACHMENTS…

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Clean area footwear cleaning & sanitization 1.0  PURPOSE: To lay down the procedure for clean area foot ware cleaning & sanitization. 2.0     SCOPE :                                   This SOP is applicable for foot ware cleaning & sanitization for clean area of SVP section  3.0       REFERENCE(S) & ATTACHMENTS: 3.1       References 3.1.1    In-House 3.2       Attachments 3.2.1    Attachment: I…

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Entry & Exit procedure for Clean Area Filling Room 1.0     PURPOSE: To provide the written procedure for entry & exit for clean area Filing room. 2.0.     SCOPE :                                   This SOP will be applicable for authorized staff & visitor’s movement in clean area   filling of SVP section. 3.0       REFERENCE(S) & ATTACHMENTS: 3.1        References 3.1.1    …

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Charging of plastic granules PURPOSE To lay down the procedure of charging of plastic granules in FFS machine. 2.0      SCOPE                                   This SOP is applicable for charging of plastic granules in  FFS machine  at SVP section  3.0       REFERENCE(S) & ATTACHMENTS 3.1       References 3.1.1    In-House 3.2       Attachments 3.2.1    Attachment: I  Granule Tank cleaning record 4.0      RESPONSIBILITY:…

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Operation & Calibration of Conductivity meter 1.0 PURPOSE: To lay down the procedure for operation & calibration of conductivity meter. 2.0      SCOPE :                                   2.1        This SOP is applicable for production department (SVP) for Operation and calibration of Conductivity meter. Make                                                 Modal Eutech                                               CON 700  3.0       REFERENCE(S) & ATTACHMENTS: 3.1       References 3.1.1    In House…

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BATCH PREPARATION OF SVP PRODUCTS 1.0     PURPOSE           To establish the written procedure for batch preparation of SVP products. 2.0     SCOPE This SOP shall be applicable for batch preparation of SVP products at SVP section 3.0     REFERENCE(S) & ATTACHMENT(S)          3.1           REFERENCE(S) 3.1.1.    USP <797> Pharmaceutical compounding sterile preparation.             3.1.2.    PIC/S “guide to GMP…

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Area cleaning and sanitization PURPOSE : To define procedure for cleaning of production and other adjacent area. SCOPE : This SOP applicable for cleaning and sanitization of furniture, fixture, floor, walls, trolley etc. REFERENCE(S) & ATTACHMENTS : 3.1       References In House 3.2       Attachments 3.8.1   Attachment -I   : Daily cleaning record 3.8.2    Attachment-II  : Approved disinfectants/cleaning…

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