Quality control procedures used during analytical testing and documentation
1.0 Purpose
1.1 To describe a procedure for the Quality Control procedure used during analytical testing and recording,
reviewing, audit and storage of analytical documents.
2.0 Scope
2.1 This standard operating procedure is applicable for the Quality Control procedure used during
analytical testing and recording, reviewing, audit and storage of analytical documents in QC Laboratory at ABC Pvt. Ltd.
3.0 Responsibility
| Officer QC/ Executive QC | Preparation of SOP |
| Assistant Manager | Reviewing and Training of SOP |
| Manager QC | Implementation of SOP |
4.0 Accountability
4.1 Manager Quality Control is accountable for implementation and compliance with SOP.
5.0 Procedure
5.1 Each Quality Control Officer / Executive shall be allocated day-to-day work, as per the SOP for work distribution.
5.2 Blank Protocol for recording of raw data shall also be issued to QC officer by Manager QC or
his authorized nominee. Protocol shall be product specific.
5.3 QC officer / executive shall perform analytical testing, as per the standard test procedure of
allocated sample and all raw data shall be recorded in protocol only.
5.4 All the supporting documents (such as chromatograms, prints etc.) shall be attached with protocols.
5.5 After completion of testing certificate of analysis (COA) shall be printed and authorized.
5.6 Completed protocol along with supporting documents, Certificate of analysis shall be signed by
analyst and checked by Manager Quality Control.
5.7 If material does not conform to the specification, it shall be informed to Manager
Quality Control/Manager Quality Assurance for further necessary action.
5.8 The protocol along with COA and supporting document (Analytical document)
shall be submitted to Manager Quality Control.
5.9 Manager Quality Control shall check the complete analytical document.
5.10 All the analytical documents shall be stored product wise and year wise in the documentation room.
6.0 Reference
In house specification
7.0 Attachments
Not Applicable
8.0 Distribution
Distribution of the controlled copy to concerned departments.
Additional copies may be issued for specific purpose.
9.0 Abbreviations
QA : Quality Assurance
QC : Quality Control
SOP : Standard Operating Procedure
COA : Certificate of analysis
10.0 Revision History
| Revision No. | Supersedes | Effective Date | Details of Revision |
| 01 | Nil | New SOP |
- process validation protocol for methylcobalamin niacinamide and pyridoxine injection
validation protocol of sterility test
sop for Analytical Method Transfer
Protocol for hold time study of sterile garments
sop for swab sampling for validation of clean surfaces
cleaning validation maco and noel calculation formula
sop for performance qualification for analyst
Sop for Validation report for disinfectant efficacy
Sop for Method validation report for bacterial endotoxin test
Sop for method validation microbiology sterility testing
sop for validation report for preservative efficacy test
sop for Protocol cum report for efficacy qualification of uv light
sop for validation protocol for uv light efficacy of dpb & laf
sop for cleaning validation protocol tablet manufacturing equipment
sop for cleaning validation protocol ointment manufacturing equipmentconcurrent process validation for rabeprazole ec and domperidone sr capsules
sop for Validation for cleaning procedure liquid injection
sop for Validation for cleaning procedure dry powder injection
Preparation Approval Control and Distribution of Master Formula Records
calibration policy for equipment and instruments
evaluation Sampling of Raw Materials questionnaire
training evaluation questionnaire
sop for approval of Contract Parties
sop for Operation and Cleaning of Purified Water Generation System
sop for Storage of Standard Weights
-
process validation protocol for methylcobalamin niacinamide and pyridoxine injection
validation protocol of sterility test
sop for Analytical Method Transfer
Protocol for hold time study of sterile garments
sop for swab sampling for validation of clean surfaces
cleaning validation maco and noel calculation formula
sop for performance qualification for analyst
Sop for Validation report for disinfectant efficacy
Sop for Method validation report for bacterial endotoxin test
Sop for method validation microbiology sterility testing
sop for validation report for preservative efficacy test
sop for Protocol cum report for efficacy qualification of uv light
sop for validation protocol for uv light efficacy of dpb & laf
sop for cleaning validation protocol tablet manufacturing equipment
sop for cleaning validation protocol ointment manufacturing equipmentconcurrent process validation for rabeprazole ec and domperidone sr capsules
sop for Validation for cleaning procedure liquid injection
sop for Validation for cleaning procedure dry powder injection
Preparation Approval Control and Distribution of Master Formula Records
calibration policy for equipment and instruments
evaluation Sampling of Raw Materials questionnaire
training evaluation questionnaire
sop for approval of Contract Parties
sop for Operation and Cleaning of Purified Water Generation System
sop for Storage of Standard Weights
sop for Verification of Weighing Balance
-
Sop for Submitting of Leave Application
sop for Accident Management Procedures
sop for Accident Management Procedures
Cleaning and colour coding of Factory Apparel (Clothes)
Job Responsibilities of Key Personnel
sop for Maintenance of Building
Destruction of Batch Production and Control Records BPCR
Procedure for Sampling of Rinse water Swab
sop for Pressure Differential Monitoring
sop of double distillation apparatus
Cleaning of quality control department
receipt storage and issuance of chemical and glassware
Quality control procedures used during analytical testing and documentation
