Remix education
pharmacystudy material

Quality assurance (Unit:-3)

Quality Control: Quality control test for containers, rubber closures and
secondary packing materials.
Good Laboratory Practices: General Provisions, Organization and Personnel,
Facilities, Equipment, Testing Facilities Operation, Test and Control Articles,
Protocol for Conduct of a Nonclinical Laboratory Study, Records and Reports,
Disqualification of Testing Facilities

Good Laboratory Practice is defined in the OECD Principles as “a quality system
concerned with the organisational process and the conditions under which non-clinical health and environmental safety studies are planned, performed, monitored, recorded, archived and reported.”
• The purpose of the Principles of Good Laboratory Practice is to promote the development of quality test data and provide a tool to ensure a sound approach to the management of laboratory studies, including conduct, reporting and archiving.
• The Principles may be considered as a set of standards for ensuring the quality,
reliability and integrity of studies, the reporting of verifiable conclusions and the traceability of data.
• The Principles require institutions to assign roles and responsibilities to staff in order to ensure good operational management of each study and to focus on those aspects of study execution (planning, monitoring, recording, reporting, archiving) that are of special importance for the reconstruction of the whole study.
• Since all these aspects are of equal importance for compliance with GLP
Principles, it is not permissible to partially implement GLP requirements and still claim GLP compliance. No test facility may rightfully claim GLP compliance if it
has not implemented and does not comply with, the full array of the GLP rules. As far as pharmaceutical development is concerned, the GLP Principles, in their regulatory sense, apply only to studies which:
• are non-clinical, i.e. mostly studies on animals or in vitro, including the analytical aspects of such studies;
• are designed to obtain data on the properties and/or the safety of items with respect to human health and/or the environment;
• are intended to be submitted to a national registration authority with the purpose of registering or licensing the tested substance or any product derived from it.
Depending on national legal situations, the GLP requirements for non-clinical laboratory studies conducted to evaluate drug safety cover the following classes of studies:
• Single dose toxicity
• Repeated dose toxicity (sub-acute and chronic)
• Reproductive toxicity (fertility, embryo-foetal toxicity and teratogenicity, peri-/postnatal toxicity)
• Mutagenic potential
• Carcinogenic potential
• Toxico-kinetics (pharmacokinetic studies which provide systemic exposure data for the above studies)
• Pharmacodynamic studies designed to test the potential for adverse effects (Safety pharmacology)
• Local tolerance studies, including phototoxicity, irritation and sensitisation studies, or testing for suspected addictive and/or withdrawal effects of drugs.
1. GLP Principles are independent of the site where studies are performed. They
apply to studies planned and conducted in a manufacturer’s laboratory, at a contract or subcontract facility, or in a university or public sector laboratory.
2. GLP is not directly concerned with the scientific design of studies. The scientific
design may be based on test guidelines and its scientific value is judged by the
(Drug) Regulatory Authority that provides marketing authorisation. However, adherence to GLP will remove many sources of error and uncertainty, adding to the overall credibility of the study. Through the application of technically valid and approved Standard Operating Procedures many sources of systematic error and artefacts may be avoided.
3. The requirement to formulate a study plan with a defined scientific purpose for the study will prevent false starts and diminish the incidence of incomplete or inconclusive studies. Respecting the GLP Principles will thus indirectly optimise
the scientific yield of studies.
4. When implementing GLP in a test facility, and particularly during training, it is important to clearly differentiate between the formal, regulatory use of the term Good Laboratory Practice and the general application of “good practices” in scientific investigations. Since the term “Good Laboratory Practice” is not a trademark protected term, any laboratory may consider that it is following good
practices in its daily work. This does not comprise GLP compliance.
5. It must be clearly understood that only adherence to, and compliance with,
all the requirements of the OECD GLP Principles constitutes real compliance
with GLP. Therefore, the use of similar terminology to describe quality practices outside the scope of GLP proper should be strongly discouraged.
Quality Assurance Quality Assurance (QA) – sometimes also known as the Quality Assurance Unit (QAU) – as defined by GLP is a team of persons charged with assuring management that GLP compliance has been attained in the test facility as a whole and in each individual study.
QA must be independent of the operational conduct of the studies, and functions as a “witness” to the whole preclinical research process.
The GLP standards require that an adequate number of trained personnel are available for the study. Typical analytical laboratories keep minimal records on the training of personnel, assuming that the quality control results in the individual tests speak for the capability of the analyst.
Under GLP standards additional records must be kept and be available for audit. This includes at a minimum
1. The resume of the individual, documenting education, prior job history, publications, presentations, patents, attendance at technical courses, and memberships in technical organizations. The resume must be updated during the course of employment to document additional training and changes in responsibilities. This document should be a brief history of the employee throughout his or her professional career and current to the time of the GLP study.
2. Training records in the organization. The personnel record should include
documentation of training, including safety training, training in GLP regulations, and test-specific training. The records must include when the training was completed, and the topics covered, along with the signatures of the trainer and trainee.
3. A thorough job description for each employee and an organization chart showing the relationship of an individual to the rest of the staff must be documented.
4. All personnel records must be archived and available for audit even if the audit takes place after that individual is no longer with the organization. The managerial and organisational requirements of GLP account for about 15% of GLP regulations but, unfortunately, are still seen by regulators and QA as one of the
principal sources of non-compliance. Without full management commitment and formal involvement of all personnel, GLP systems lack credibility and will not function as they should. Personnel are, therefore, a critical element when implementing GLP and
maintaining compliance in a laboratory.