SOP for Good Laboratory Practices

OBJECTIVE 

To provide a documented procedure for good Laboratory Practices.

SCOPE 

This procedure is applicable for good Laboratory Practices to be followed at the quality control laboratory at XYZ Limited. 

RESPONSIBILITY 

Primary: Chemist-Quality Control department. 

Overall: Manager Quality control department

PROCEDURE 

The following types of laboratory facilities are necessary for assuring the quality of Active pharmaceutical products: 

Premises:

• Quality control labs should be well designed, equipped, and maintained, and have sufficient space to suit the operation to be performed in them. 
• There should be provisions for writing, recording, and storage of control samples, chemicals, and documents. 
• A separate room is necessary to keep sensitive instruments free from temperature and humidity variations and dust particles. 

Equipment:

• Quality Control labs should be fully equipped with appropriate instruments for the testing procedures. 
• Instruments should be calibrated at suitable specified intervals of time and readily available. Records should be maintained of the same. The records should indicate the next calibration date. 
• Defective equipment/Instrument should be withdrawn from use until the fault has been rectified. 

Cleanliness:

• Quality Control labs should be kept clean in accordance with the written procedure. 
• A written procedure for cleaning the glass apparatus for chemical assay should be available. 
• Personnel should wear clean, protective clothing appropriate to duties being performed. 

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Sampling: 

• Samples should be taken in such a manner that they are representative samples in accordance with their written sampling procedure. For this statistical control norms can be adopted

• The sampling procedure should include: 

1. Method of sampling. 
2. Equipment to be used. 
3. Amount of sample taken. 
4. Any special precautions or instructions to be followed. 

• Raw materials shall be collected as per the lot numbers or batch numbers given by the manufacturer. 
• Each container should bear a label indicating: 

1. Name of the material. 
2. Date of collection/receipt. 
3. Batch / Lot number. 
4. Name of the manufacturer and supplier. 
5. Date of manufacturing/expiry. 
6. Status label: ‘UNDER TEST’, ‘APPROVED’, AND ‘REJECTED’. 

Documentation: 

• It indicates the test procedure, specifications, standards, limits, and detailed analytical reports. 
• Raw material analysis records indicate: 

1. Name of the material with code number and reference number. 
2. Date of receipt, date of sample collected, date of analysis, completion data 
3. Number of containers received and number of samples collected. 
4. Detailed analytical report indicating standards and specifications, status of sample, with approved signatures.

Finished product records indicating:

• Name of the material with code number and reference number. 
• Date of receipt, date of sample collected, date of analysis, completion data. 
• Detailed analytical report indicating standards and specification, status of sample, with approved signatures. 

• Record of in-process materials/intermediates. 

1. Record of standard/normal solution indicating periodically its validity, with the date and authorized signature. 
2. Reference standard records determining the potency/purity periodically with date and signature. 
3. Records of water analysis used for analytical purposes. 
4. Control sample records showing its location, date of receipt, and quantity received. 
5. List of various chemicals used. 
6. Stability data of all products. 

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Instrumentation and Calibration:

• Analytical balances should be checked at least annually against weights traceable to the National Bureau of Standards Calibration. 
• The accuracy of the calibration of the pH meter should be checked using known buffers. 
• Spectrophotometers should be checked about their photometric accuracy, reproducibility, resolution, and wavelength. 
• Thermometers should be checked against the Standard Thermometers of the National Bureau of Standards Calibration. 
• Dissolution apparatus shall be checked for both physical and chemical calibration 
• FTIR shall be checked for wavenumber accuracy and repeatability. 
• HPLCs shall be checked for calibration of the Pump, detector, and injector calibration. 

Controls:

• CHEMICAL: A specially prepared test solution should be used for checking the accuracy of various tests. 
• Karl Fischer Moisture Test: Test one or more hydrated compounds to compare the theoretical water content obtained. 
• Infra-red and UV Identity: Maintain spectra of each active ingredient of the reference standard. 
• Checking all the manufacturing and in-process data along with the analytical data before the final release.

Specifications:

• Specifications approved by Quality Control should be available for: 

1. Starting material 
2. Finished products 
3. Packing material 
4. Intermediates. 

Facilities:

• Fuming chamber/exhaust fan 
• Cross ventilation/air conditioning facilities. 
• Chemical and glassware storage. 
• Fire extinguishers. 

Training:

• Chemists, analysts, lab assistants, should be trained to know the importance and technical importance of all GMP norms. 

ABBREVIATION

GMP: Good Manufacturing Practices 

UV: Ultra-violet spectrophotometer 

FTIR: Fourier Transform Infrared spectrophotometer 

HPLC: High-Performance Liquid Chromatography 

REVISION HISTORY

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