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 fall under different heads and the essentials of each are briefly outlined below:
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
- 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
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.
- 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 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 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.
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.