Editable Quality Assurance SOP

Editable Quality Assurance SOP Free Download

Editable Quality Assurance SOP Free Download

Editable Quality Assurance SOP Free Download

Welcome to “Editable Quality Assurance SOP,” your premier source for pharmaceutical manufacturing SOPs tailored for the quality assurance department. Our blog provides editable SOPs designed to meet the stringent standards of the pharmaceutical industry. Stay informed with the latest regulatory updates, best practices, and expert guidance to ensure your quality assurance processes are compliant, efficient, and effective. Join us in achieving excellence in pharmaceutical manufacturing.

Editable Quality Assurance SOP:

S. No.

SOP No.SOP Title

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1QA001SOP ON SOP

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2QA002Format Issuance and Control

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3QA003Change Control System

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4QA004Deviation control

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5QA005Training of Plant Personnel

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6QA006Site Master File

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7QA007Preparation of General Test Procedures

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8QA008Validation of equipments / instruments / system / process / method.

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9QA009Procedure For Issuance of  BMR &BPR in Production Department

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10QA010

Batch Numbering System

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11
QA011
Initiation and execution of stability studies

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12QA012Investigation Of Laboratory Failure Results During Stability Studies

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13QA013Validation Master Plan

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14QA014Preparation and Control of product Manual, Batch Manufacturing Record (BMR)and Batch Packing Record(BPR)

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15QA015Procedure for Review of BMR&BPR

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16QA016Job Responsibilities

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17QA017Procedure for Documentation & Recording In Quality Assurance

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18QA018Preparation , Issuance & Retrieval of Analytical Test Data Sheets

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19QA019Batch Release

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20QA020Annual Product Review

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21QA021Handling Of Rejected Material

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22QA022Handling Of Returned Goods

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23QA023Procedure For Handling Of Out Of Specification Results

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24QA024

Documents Storage Period

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25QA025Procedure For Expiry Date

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26QA026Assigning code numbers to Raw material, Packing material and Finished products

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27QA027Self Inspection

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28QA028Review Of Documents

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29QA029Equipment Numbering System

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30QA030Personnel Qualification

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31QA031Corrective & Preventive Action For Non-Conforming Results in Total Microbial Count in Water Samples

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32QA032Investigations

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33QA033

Authorized Signatories

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34QA034Procedure for Validation Criteria

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35QA035To Make Correction In Records

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36QA036

Handling Of Market Complaints

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37QA037Investigation Of Non-conforming Material

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38QA038Non-Conforming Material Review & Disposition

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39QA039Preparation Of Art Works

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40QA040Vendor Qualification

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41QA041Sampling Of In Process and Finished Drug Product

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42QA042

Disinfectant Usage Policy

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43QA043Control Of Product Labels

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44QA044Handling And Control Of Drawings / Schematic Layouts

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45QA045Procedure For Product Recall

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46QA046Corrective & Preventive action for Non-conforming results in Microbiological Environmental Monitoring

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47QA047Procedure For Batch Record Docket Archival

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48QA048Common Vendor Qualification & Approval for Packing Material

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49QA049Procedure For Sampling And Analysis Of Water Sample After Cleaning

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50QA050Preparation and control of Master formula record

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51QA051Procedure for Sampling of Finished Product

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52QA052Sampling of IN-Process Samples

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53QA053Analysis and Release of Finished Product Samples.

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54QA054Line Clearance Procedure for Manufacturing and Packing Operation

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Also; Visit:

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