The document lists 38 standard operating procedures (SOPs) for a quality assurance department. The SOPs cover topics such as quality assurance manuals, audits, sampling, material and product release or rejection, market complaints, product recalls, line inspections for various production sections, monitoring of dispensing, material inspections, validation programs and processes, packaging controls, cleaning validation, machine qualifications, out of specification materials and products, deviation handling, annual product reviews, document controls, area clearances, HVAC validation, filter testing, document numbering, vendor validation, water treatment, material destruction, batch record submission, personnel training, test result verification, and calibration.
Original Description:
list of SOP's for Quality Assurance Department
Original Title
list of SOP's for Quality Assurance Department
The document lists 38 standard operating procedures (SOPs) for a quality assurance department. The SOPs cover topics such as quality assurance manuals, audits, sampling, material and product release or rejection, market complaints, product recalls, line inspections for various production sections, monitoring of dispensing, material inspections, validation programs and processes, packaging controls, cleaning validation, machine qualifications, out of specification materials and products, deviation handling, annual product reviews, document controls, area clearances, HVAC validation, filter testing, document numbering, vendor validation, water treatment, material destruction, batch record submission, personnel training, test result verification, and calibration.
The document lists 38 standard operating procedures (SOPs) for a quality assurance department. The SOPs cover topics such as quality assurance manuals, audits, sampling, material and product release or rejection, market complaints, product recalls, line inspections for various production sections, monitoring of dispensing, material inspections, validation programs and processes, packaging controls, cleaning validation, machine qualifications, out of specification materials and products, deviation handling, annual product reviews, document controls, area clearances, HVAC validation, filter testing, document numbering, vendor validation, water treatment, material destruction, batch record submission, personnel training, test result verification, and calibration.
No. 01 Quality Assurance Manual 02 Sop for GMP Audit/ Self Inspection 03 Sop for sampling 04 Sop for Release or Rejection of Materials 05 Sop for Release or Rejection of Finished Products 06 Sop for Market Complaints 07 Sop for Product Recall 08 Sop for Line Inspection Injectable Section 09 Sop for Line Inspection Steroid tablet Section 10 Sop for Line Inspection General Tablet Section 11 Sop for monitoring of Dispensing 12 Sop for Line Inspection of Infusion Section 13 Sop for Line Inspection of Veterinary Injectable Section 14 Sop for Inspection of Incoming Raw Materials 15 Master Validation Program 16 Sop for Process Validation (Sterile Area) 17 Sop for Process Validation (Non-Sterile Area) 18 Sop for Control of Packaging Process 19 Sop for Cleaning Validation 20 Sop for Performance Qualification of Machines 21 Sop for Out of Specification of Materials 22 Sop for Out of Specifications of Products 23 Sop for Deviation Recording & Handling 24 Sop for Annual Product Review 25 Sop for Document Creation, Control, Review & Obsolete 26 Sop for Line Clearance of Manufacturing Areas 27 Sop for Line Clearance of Packaging Areas 28 Sop for HVAC Validation 29 Sop for DOP Test of HEPA Filters 30 Sop for Issuance of Document Number 31 Sop for Vendor Validation/ Supplier Evaluation 32 Sop for Performance of Water Treatment Section 33 Sop for Destruction of Material 34 Sop for Submission of Batch Record (BMR & BPR) 35 Sop for Specific Training of Personnel’s 36 Sop for Continuous Training of Personnel’s 37 Sop for Verification of Test Results 38 Sop of Calibration