Category: SOPs

SOPs

Procedure For Product Recall

Posted on By ABHA

  Procedure For Product Recall STANDARD OPERATING PROCEDURE Title : Procedure For Product Recall          OBJECTIVE To lay down the Procedure for product recall. SCOPE This Procedure is applicable for Handling of Product Recalls at Pharmaceutical Company. RESPONSIBILITY It is a Joint responsibility of the Marketing Department in coordination with Quality Assurance Head-Export / Company Appointed Business agent of the country in coordination with Quality Assurance. Manager – Quality Assurance ACCOUNTABILITY Manager-QA VP-Plant & Operations….

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SOPs, Uncategorized

Assigning Manufacturing and Expiry date to the Finished Products

Posted on By ABHA

Assigning Manufacturing and Expiry date to the Finished Products Objective To lay down a procedure for assigning manufacturing and expiry date to the finished products manufactured. Scope This procedure shall be applicable to all products manufactured. Responsibility Executive / Officer Production shall be responsible for assigning manufacturing and expiry date to batch of finished product…

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SOPs

SOP on Receipt of Raw Materials and Packaging Materials

Posted on By ABHA

SOP on Receipt of Raw Materials and Packaging Materials Objective: To lay down a procedure for receiving the raw materials and packaging materials. Scope: This SOP is applicable for receipt of Raw and Packing material to warehouse of formulation plant. Responsibility: Officer or above-warehouse is responsible for receipt of raw materials and packing materials Accountability:…

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SOPs

Procedure For action to be taken during spillage /breakage of materials.

Posted on By ABHA

Procedure For action to be taken during spillage /breakage of materials 1.0    OBJECTIVE To lay down procedure for action to be taken during spillage /breakage of materials. SCOPE 2.1   This procedure is applicable to Warehouse and Quality Control departments for equipment cleaning and operation at pharmaceutical company. RESPONSIBILITY Warehouse Chemist concerned department – To clean…

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SOPs

SOP For Procedure For change control system

Posted on By ABHA

SOP For Procedure For change control system OBJECTIVE      To lay down the Procedure for change control System. SCOPE The purpose of this SOP is to describe in details the change control process. This procedure starts from initiation to the implementation of the change at Pharmaceutical Company. RESPONSIBILITY Originating/ initiating Department:     To initiate the…

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SOPs

Procedure for review, audit and storage of batch records and testing records

Posted on By ABHA

Procedure for review, audit and storage of batch records and testing records Objective: To lay down a procedure for review, audit and storage of batch records and testing records. Scope: This procedure is applicable to Quality Assurance, Quality Control and Production department of Formulation Plant of Pharmaceutical Company. Responsibility: QA officer / executive shall be…

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SOPs

SOP For format issuance and control

Posted on By ABHA

SOP For format issuance and control  OBJECTIVE To lay down the Procedure for format issuance and control. SCOPE RESPONSIBILITY Executive-Quality Assurance ACCOUNTABILITY Manager-Quality Assurance. PROCEDURE DOCUMENT CONTROL & ISSUANCE All formats originating from the SOPs shall be taken on a stand This SOP is applicable for all departments to control documents, which are Approved and…

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SOPs

Procedure for the Cleaning of Comminuting Mill

Posted on By ABHA

Procedure for the Cleaning of Comminuting Mill Objective To lay down the procedure for the Cleaning of Comminuting Mill. Scope This Standard Operating Procedure is applicable for formulation plant Make: Clit, Responsibility Trained worker / Operator shall be responsible for cleaning the machine as per this SOP. Production Supervisor / Officer shall be responsible for…

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SOPs

Reporting, Investigating and Disposition of Incidents in Quality Assurance Department

Posted on By ABHA

Reporting, Investigating and Disposition of Incidents in Quality Assurance Department OBJECTIVE : To lay down a procedure for reporting, investigating and disposition of incidents in Quality Assurance Department. RESPONSIBILITY : Officer-QA to raise Incident Report  to allot number & due date to the Incident Report. Officer-QA & Head-QA or his designee to investigate and take necessary…

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SOPs

Storage, Retrieval, Control and Retention of all completed Documents

Posted on By ABHA

Storage, Retrieval, Control and Retention of all completed Documents OBJECTIVE : To outline a procedure for the storage, retrieval, control and retention of all completed documents, related to various functional areas  to ensure security and traceability of completed records. RESPONSIBILITY : Concerned HOD or his designee to arrange for submitting respective completed documents related to their functional area….

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SOPs