Department Document No.

WEATHER FOLDS
Quality Control WF/ QCD/GSOP/021
PHARMACEUTICAL
Effective Date Next Revision Date
Standard Operating Procedures 01-01-2019 01-01-2021
Revision Date Revision No.
Good Laboratory Practices 01-01-2019 06
Prepared by: Sign with Date Reviewed by: Sign with Date Approved by: Sign with Date Authorized by: Sign with Date

Quality Assurance
Quality Control Analyst Quality Control Manager Manager /QMR Plant Manager
1.0 Purpose

It is established to provide the procedure for Good Laboratory Practices.

2.0 Scope

This SOP is applicable to Quality Control Department.

3.0 Responsibility

a. Quality Control Manager

Responsible for ensuring of proper implementation of SOP.

b. QC Analyst / Lab assistant

Responsible for follow up of this SOP.

4.0 Description

A good laboratory practice is a part of cGMP, which is exercised due to the following
reasons.
1 To produce consistent quality products.
2 To ensure reliability and accuracy of results.
3 To maintain, calibrate and validate the equipments.
4 To prepare QSP’s & SOP’s for proper handling and usage of equipments.
5 To prepare authorized and updated specifications for raw material, inprocess materials
packaging materials, bulk and finished products.
6 To maintain working standards for proper evaluation of raw materials as well as in
process and finished products.
7 To document the record at each and every stage properly.
8 Stability testing to ensure chemical, physical, microbiological, therapeutic and
toxicological safety of our products.

(a) Premises:
1. The quality control department shall have adequate space for proper testing covering
routine and specialized procedures.
 Department Document No.
WEATHER FOLDS
Quality Control WF/ QCD/GSOP/021
PHARMACEUTICAL
Effective Date Next Revision Date
Standard Operating Procedures 01-01-2019 01-01-2021
Revision Date Revision No.
Good Laboratory Practices 01-01-2019 06
Prepared by: Sign with Date Reviewed by: Sign with Date Approved by: Sign with Date Authorized by: Sign with Date

Quality Assurance
Quality Control Analyst Quality Control Manager Manager /QMR Plant Manager
2. The QC department shall have separate are for highly sensitive instruments to protect
these against electrical interference, vibrations contact with excessive moisture and
other external factors.

3. The Q department shall have adequate facility for testing of sterile preparations and
microbiologically controlled products.

4. Have adequate facility for animal care.

5. The QC department should be equipped with personal safety equipments.

6 The QC department shall have adequate area for storage of chemical solvents
retention samples and samples for stability studies.

(b) Personnel and Organization:

1. The QC department shall have proper structure to support quality control activities.
2. The QC department shall have qualified and experienced staff.
3. The staff should be technically competent.
4. The QC staff shall be aware of requirements of personnel hygiene and health
persecutions.
5. The QC staff should be sufficient in number for the timely and proper conduct of the
testing.

(c) Quality assurance Department:

1 An independent Quality Assurance department should exist which shall be

responsible for Monitoring that the facilities, equipments, personnel, Methods,
Practice, Records and controls are in conformance with the regulations.

2 Determine that no deviation from approved protocols or Sop’s were made without
proper authorization and documentation

3 Supervising all stability studies, process validation, installation operation (IO),

Qualification operation (QO), and performance operation (PO).

(d) Equipments and Calibration:

1. Equipments used in the generation measurement or assessment of data or environment

control shall be of appropriate design and capacity
 Department Document No.
WEATHER FOLDS
Quality Control WF/ QCD/GSOP/021
PHARMACEUTICAL
Effective Date Next Revision Date
Standard Operating Procedures 01-01-2019 01-01-2021
Revision Date Revision No.
Good Laboratory Practices 01-01-2019 06
Prepared by: Sign with Date Reviewed by: Sign with Date Approved by: Sign with Date Authorized by: Sign with Date

Quality Assurance
Quality Control Analyst Quality Control Manager Manager /QMR Plant Manager
2. Equipments shall be adequately inspected, cleaned, maintained, tested and calibrated.
3. Written S.O.P, S shall be available for proper handling/ usage and reproducibility.

(a) Specifications:
1. Appropriately authorized and dated specifications should be available for raw material
in process materials, packing material, bulks and finished products.

2. Updating of specification in case of changes in the monograph.

(b) Standard Operating Procedures:
1. Standard operating procedures in writing should be available for all the activities
being carried out in the laboratory.

2. Changes in the Sop’s should be properly authorized.

3. A historical file of Sop’s and revisions these of including the dates of such revision
should be maintained.

(d) Reagents:

1. All the reagents and solutions used in the laboratory should be labeled to indicate
identity, concentration, storage requirements and expiration date.

2. Deteriorated or outdated reagents and solutions should not be used.

(e) Reference Standards:

1. Laboratory should have sufficient quantities of reference standards for proper

evaluation of raw materials.

2. Working standards may be developed form the reference standards.

(f) Sampling:

1. Proper SOP to carry out sampling of raw and packing material, in process material,
bulks and finished products.

2. Specific (Sterile) containers to be used for the sampling of sterile materials.

3. Sampling plan should be based on randomly selected samples, representative of whole

population.

(g) Documentation, Data and Record:

 Department Document No.
WEATHER FOLDS
Quality Control WF/ QCD/GSOP/021
PHARMACEUTICAL
Effective Date Next Revision Date
Standard Operating Procedures 01-01-2019 01-01-2021
Revision Date Revision No.
Good Laboratory Practices 01-01-2019 06
Prepared by: Sign with Date Reviewed by: Sign with Date Approved by: Sign with Date Authorized by: Sign with Date

Quality Assurance
Quality Control Analyst Quality Control Manager Manager /QMR Plant Manager
1. All the test data should be properly documented.

2. Record should be kept for a specific period of time.

3. Record should be kept in retrievable manner.

4. Material safety data sheets should be available for all chemicals and solvents used in
the laboratory.

5. When working with computer systems special case should be taken regarding data
integrity and security (changes to electronic file by unauthorized users.)

(h) Validation:
1. Master validation scheduled/ plan should be prepared.
2. Master validation plan should cover equipments methods systems.
3. Validation of computer systems must include the qualification of hardware and soft
wares.
4. Validation protocols and validation reports should be prepared

(i) Training:

1. Training activities to be regularly carried out (Analysis, Safety, and use of

Equipments)
2. Training record to be maintained.
3. Skill inventory is to be carried out.
4. Grading of analyst may be carried out on the basis of skill level.
5. Training effectiveness is to be measured.

(j) House Keeping:

1. Every individual should be responsible for keeping the house laboratory work Place)
clean tidy and organized.

2. Disposal of tested samples, solvents, reagents and chemicals should be in

environmental friendly manner.

3. Smoking eating, drinking chewing and keeping plants food or smoking material and
personal medicine should not be permitted in laboratory.
 Department Document No.
WEATHER FOLDS
Quality Control WF/ QCD/GSOP/021
PHARMACEUTICAL
Effective Date Next Revision Date
Standard Operating Procedures 01-01-2019 01-01-2021
Revision Date Revision No.
Good Laboratory Practices 01-01-2019 06
Prepared by: Sign with Date Reviewed by: Sign with Date Approved by: Sign with Date Authorized by: Sign with Date

Quality Assurance
Quality Control Analyst Quality Control Manager Manager /QMR Plant Manager
4. Adequate facilities for collection and disposal of test animals waste or refuse to
minimize doors hazard to vermin infestation and environmental contamination.