Essentials of Good Laboratory Practices (GLP)

Quality Product testing is the backbone for promotion of global trade. A product tested and approved to meet defined specifications should qualify when tested in any other laboratory.

Good laboratory practices (GLP) are an essential ingredient of a quality system that ensures uniformity, consistency, reliability and reproducibility of data. In other words the data generated using GLP practices is a true reflection on work or study and is traceable to internationally accepted standards.

ISO has evolved several standards that strengthen GLP practices. ISO 17025:2005 in particular lays down the guidelines for accreditation of calibration and testing laboratories.

The Drugs and Cosmetics Rules laid down by government of India refer to GLP guidelines in schedule L – 1.
Organization for Economic Co-operation and Development (OECD) national guidelines promote the quality and validity of test data used for chemicals and chemical products.

GLP Requirements

GLP requirements fall under different heads and the essentials of each are briefly outlined below:

General requirements

These relate to planning process which involves :

  • Developing policy and quality plan to achieve organization objectives
  • Designing organization structure to carry out plans
  • Dividing the total work in logical pattern and assigning responsibility for each activity
  • Defining relationship and coordination of work of internal departments and interaction with outside agencies to achieve company mission
  • Design system for quality evaluation, audits and surveillance of products

Premises

  • Laboratory should be located in area free from noise, dust and vibrations
  • Layout planning for different sections to avoid cross contamination
  • Test and Storage area should be separate and restricted to authorized persons only
  • Sufficient space should be provided for carrying out testing procedures
  • An effluent treatment plant is necessary if laboratory waste contains harmful pollutants
  • Centralised air-conditioning is recommended to reduce cross contamination and to control moisture levels
  • Floors should be impervious and washable

Animal house facilities

Under this all the rules relating to prevention of cruelty to animals should be taken into consideration

Manpower

Personnel are the most important resource in any organization. Laboratory should have sufficient staff with the required educational background and with the ability to perform all the responsibilities laid down by the quality manager. Proficiency test and various training programs should be conducted to improve the personal knowledge and skills.

Equipment

  • Testing laboratory should provide and maintain suitable equipment required for testing procedures.
  • Maintenance, calibration and validation of equipment is necessary to keep equipment in good working condition and improve both the efficiency and accuracy of results
  • Installation qualification IQ, operational qualification (OÓ) and performance qualification (PQ) should be performed for all new instruments and when major accessories are added.
  • Analytical instruments should be kept in clean environment with controlled temperature and humidity. Records of temperature and humidity should be maintained and made available whenever required.
  • Instrument should be calibrated throughout and defective instruments should be labeled ‘out of order ‘till they are repaired

Chemicals and reagents

Chemicals and reagents should be stored and labeled according to their physicochemical properties. The label should clearly indicate date of expiry.

SOP should be there for preparation of solutions and standardization

Reference Materials

Reference materials use is recommended due to their due to their high purity, critical characteristics and suitability

Reference standards can be used for to prepare secondary standards or working standards with the traceability to primary reference standard

Quality Systems

Quality manual is the main document which helps to maintain the product quality and is the permanent reference for the implementation and maintenance of quality system which describes both the management requirements as well as customer requirements.

Standard operating procedures

Standard operating procedures are documented procedures in chronological order listing established procedures and processes essential for upkeep of established quality management systems.

Good housekeeping and safety

Written instructions for good housekeeping and should be communicated to the staff through handouts, audio visuals or other methods.

Audits

Both internal and external audits should not be considered additional burden but on the contrary help maintain and improve quality standards.

The outlined requirements are touched upon in brief. GLP in itself is a vast area and there can be variations leaving scope for innovation by individual laboratories in defining their own quality policies..

Please do leave your comments based on your specialization and experience.

About the Author:

Mahima Agarwal is a pharma professional specializing in Pharmacognosy. After her postgraduation from Rameesh Institute, Greater NOIDA, India she is working with Arbro Pharmaceuticals, New Delhi for last 2.5 years. Mahima has rich exposure to analysis and standardization of herbal medicines and health supplements.

Comments

  1. Samuelle J. says:

    I absolutely agree with what you’ve written about audits and that they help maintain and improve quality standards. Getting to know more about clinical audits is important, due to the fact, that all clinical research organisations are subjects of audits. Clinical audit is a very important tool for quality improvement especially for improving the care to patients. It’s necessary for clinical research organisations’ personnel to undergo such clinical audit trainings in order to improve their knowledge about these audits and to be prepared for the challenging issues they may face.

  2. emmanuel nyarko says:

    thank you for the information, i would like you to clear my doubt on this question. is it a good practice to stand in the laboratory and write your report after analysis that involve highly volatile organic solvent.

    • Hi,
      You should have a well ventilated laboratory in the first place as I would not recommend even carrying out analysis in a lab which has no provision for exhaust of such vapours. Under requirements of GLP the results should be at least entered in records simultaneously as you make your observations.It is desirable to make reports also simultaneously but due to urgency you may postphone it or delegate the authority to another group of laboratory which is dedicated for report generation.

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