SOP on Pharmacopeial updation of documents as per the Pharmacopeial changes

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SOP on Pharmacopeial updation of documents as per the Pharmacopeial changes Objective: To lay down a procedure for Pharmacopeial updation of documents as per the Pharmacopeial changes. Scope: This procedure is applicable to Pharmacopeial updation of documents as per the Pharmacopeial changes.. Responsibility: QC Chemist or above & QA officer or above Accountability: Head Quality Control & Head Quality Assurance Procedure: … Read more

SOP on Retesting of Raw Material

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SOP on retesting of raw material Objective: To lay down the procedure for re-testing of raw material for material lying in warehouse for longer period. Scope: This SOP is applicable for retesting of raw material for material lying in warehouse for longer period. Responsibility: Chemist or above of QC Department & Officer or above of warehouse Department. Accountability: Head – … Read more

SOP on Sampling of Raw Material

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SOP on Sampling of Raw Material Objective: To lay down the procedure for sampling of raw material. Scope: This procedure is applicable for sampling of raw material Responsibility: Chemist or above Accountability: Head – Quality Control Procedure: Sampling of Raw Materials: Raw material sampling shall be initiated after receiving the “GRN” from warehouse. Ensure that material is received from … Read more

SOP FOR INCIDENCE HANDLING

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SOP FOR INCIDENCE HANDLING PURPOSE: To lay down a procedure for reporting, investigation and disposition of Incidents. SCOPE: this procedure is applicable to the reporting of investigation and disposition of unplanned, uncontrolled incidents either directly or indirectly associated with Manufacturing/Packaging, or Analytical operations. RESPONSIBILITY: Observer / Concerned Department Officer shall report the Incident. Observer / … Read more

SOP FOR HANDLING OF OUT OF CALIBRATION

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SOP FOR HANDLING OF OUT OF CALIBRATION PURPOSE: To lay down a procedure for handling of out of calibration of instruments. SCOPE: This SOP is applicable for all the instruments available. RESPONSIBILITY Preparation of SOP: Officer /Sr. Officer QA Department. Checking and Review of the SOP: Officer /Executive QA Department. Approval of the SOP: Executive … Read more

CHECKLIST FOR PREVENTIVE MAINTENANCE OF COMPRESSION MACHINE

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CHECKLIST FOR PREVENTIVE MAINTENANCE OF COMPRESSION MACHINE Equipment code: ___________________________ Frequency:  Quarterly Open and clean the panel internally and externally using vacuum cleaner/air blower. Visually check the tightness of cable termination at MCCB incoming and outgoing side and at outgoing MCB. Check the operation and setting of all machine interlocking. Check all terminations for overheating. … Read more

SOP on writing & approval of Qualification and validation protocol & reports

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SOP on writing & approval of Qualification and validation protocol & reports Objective: To describe the procedure for writing & approval of qualification and validation protocols & reports. Scope: This SOP is applicable to all type of qualification and validation protocol & report for all department to Formulation plant. Responsibility: The officer / executive / section in-charge … Read more

SOP FOR CLEANING VALIDATION

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SOP FOR CLEANING VALIDATION PURPOSE: To describe the procedure for Cleaning Validation studies to be followed for equipment/ accessories used in manufacturing. SCOPE: This SOP is applicable for documented evidence and actual experimental data that the procedure being followed for cleaning of equipment and accessories is effective and removes all residues of previous product up to … Read more

SOP FOR HANDLING OF ON-LINE REJECTIONS

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SOP FOR HANDLING OF ON-LINE REJECTIONS PURPOSE:  To lay down the procedure for On-line rejected materials. SCOPE: This SOP is applicable to all Raw and packing materials. RESPONSIBILITY Production officer or Executive shall be responsible to initiate online rejection note QA personnel shall issue online rejection note. IPQA personnel shall verify online rejection note. QA head/ … Read more

SOP FOR PROCEDURE FOR NUMBERING, CLEANING AND SANITIZATION OF DRAIN POINTS

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SOP FOR PROCEDURE FOR NUMBERING, CLEANING AND SANITIZATION OF DRAIN POINTS PURPOSE:  The purpose of this Standard Operating Procedure is to provide guidance for numbering, cleaning and sanitization of drain points.        SCOPE: This procedure is applicable for numbering, cleaning and sanitization of drain points of all department. RESPONSIBILITY: Preparation of SOP: Officer/ Sr. Officer … Read more