Good Laboratory Practices.

1.0       Purpose    :    To provide instruction good laboratory practices.

2.0         Objective  :    To provide a documented procedure for good laboratory practices.

3.0           Scope     :     This procedure is applicable for good laboratory practices follow.

4.0         Responsibility   :

·              Primary: Chemist    :   Officer of respective department.

·              Overall Responsibility     :    Respective department Head.

5.0       Procedure  :

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

·              Premises :

Ø           Control labs should be well designed, equipped, maintained and has sufficient space to suit the operation to be performed in them.

Ø           There should be provisions for writing, recording, storage of control samples, chemicals and documents.

Ø           A separate room is necessary to keep sensitive instruments free from temperature humidity variations and dust particles.

Ø           Chemical, and Microbiological labs should be separate from each other.

·              Equipments :

Ø           Control lab should be fully equipped with appropriate instruments for the testing procedures.

Ø           Equipments and instruments should be serviced and calibrated at suitable and 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.

Ø           Defective equipment should be withdrawn from use until the fault has been rectified.

·              Cleanliness :

Ø           Control lab should be kept clean in accordance with the written procedure.

Ø           A written procedure for cleaning the glass apparatus of chemical assay should be available.

Ø           Personnel should wear clean, protective clothing appropriate to duties being performed.

·              Sampling:

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

Ø           The sampling procedure should include:

Ø           Method of sampling.

Ø           Equipment to be used.

Ø           Amount of sample taken.

Ø           Any special precautions or instructions to be followed.

Ø           Raw materials are to be collected as per the lot numbers or batch numbers given by the manufacturer.

Ø           Each container should bear a label indicating:

Ø           Name of the material.

Ø           Date of collection / receipt.

Ø           Batch / Lot number.

Ø           Name of the manufacturer and supplier.

Ø           Date of manufacturing / expiry.

Ø           Status label: ‘UNDER TEST’, ‘APPROVED’, AND ‘REJECTED’.

·              Documentation:

Ø           It indicates the test procedure, specification, standards, limits and detailed analytical reports.

Ø           Raw material analysis record indicating:

Ø           Name of the material with code number and reference number.

Ø           Date of receipt, date of sample collected, date of analysis, completion data

Ø           Number of containers received and number of samples collected.

Ø           Detailed analytical report indicating standards and specification, status of sample, with approved signature.

Ø           Finished product record indicating:

Ø           Name of the material with code number and reference number.

Ø           Date of receipt, date of sample collected, date of analysis, completion data.

Ø           Number of containers received and number of samples collected.

Ø           Detailed analytical report indicating standards and specification, status of sample, with approved signature.

Ø           Record of in-process materials / intermediates.

Ø           Record of standard / normal solution indicating periodically its validity, with date and authorized signature.

Ø           Reference standard records determining the potency / purity periodically with date and signature.

Ø           Records of water analysis used for analytical purpose.

Ø           Control sample record showing its location, date of receipt, quantity received, date of removal indicating the reason and the product details with the authorized signature should be maintained.

Ø            List of various chemicals used.

Ø           Stability data of all products.

Ø           Market complaint record indicating the details:

Ø           Nature of the product.

Ø           Manufacturing

Ø           Nature of complaint.

Ø           Region from which complaint received.

Ø           Quality Assurance Department investigation / remark / action.

·              Instrumentation and Calibration :

Ø           Analytical balance should be checked at least annually against weights traceable to National Bureau of Standards Calibration.

Ø           The accuracy of the calibration of pH meter should be checked using known buffers.

Ø           Spectrophotometers should be checked with regard to their photometric accuracy, reproducibility, resolution, and wavelength.

Ø           Thermometers should be checked against Standard Thermometer of National Bureau of Standards Calibration.

Ø           Water baths, refrigerators, incubators should be checked for their distribution of uniform temperature by a calibrated thermometer.

·              Controls  :

Ø           CHEMICAL: Specially prepared test solution should be used for checking the accuracy of various tests.

Ø           Karl Fischer Moisture Test: Test one or more hydrated compound to compare the theoretical water content obtained.

Ø           Infra- red and UV Identity: Maintain spectra of each active ingredient of reference standard.

Ø           Checking all the manufacturing and in-process data along with the analytical data before the final release.

Ø           The transfer of entries from the note books to the final records is to be cross checked by the authorized person.

·              Specifications:

Ø           Specifications approved by Quality Control should be available for:

Ø           Starting material

Ø           Finished products

Ø           Packing material

Ø           Intermediates.

·              Facilities:

Ø           Fuming chamber / exhaust fan

Ø           Vacuum line.

Ø           Cross ventilation / air conditioning facilities.

Ø           Lock room facility to store poisonous material.

Ø           Chemical and glass ware storage.

Ø           Fire extinguishers.

·              Returned Goods and Reprocessing Goods:

Ø           A finished product returned from the depot or market may be relabeled, provided there is no risk to the product quality and therapeutic value.

Ø           Mix-up during relabeling should be avoided.

Ø           Additional tests of reprocessed product should be considered.

·              Training :

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

 

6.0      Reference Document     :  Not Applicable.

7.0      Abbreviations :

·              QA   = Quality Assurance department

·              SOP = Standard Operating Procedure

·              GMP = Good Manufacturing Practices

·              GLP = Good Laboratories Practices

8.0      Copies to  Distribution Sites:

·              QA

·              QC