APPLICATION PROCESS FOR COMPLIANCE STATUS … Laboratory Practice Compliance.pdf · APPLICATION...

APPLICATION PROCESS FOR COMPLIANCE STATUS

Facilities applying for GLP Compliance Status will have to follow the process below:• Facilities complete the application form (F14 TC), providing details of types of chemicals tested, areas of expertise, staff, equipment and facilities to SANAS;•• SANAS provides prospective applicants with a detailed quotation;• Facilities submit supporting information and documentation (manuals, site plans, a master schedule, relevant SOPs, organisation structures);• The lead inspector conducts a document review prior to the pre-inspection visit. Facilities shall have completed one study in compliance with the OECD completed one study in compliance with the OECD Principles of GLP prior to the initial inspection visit;• The applicant organisation receives written notification of the proposed inspection dates• Two weeks prior to the inspection, the lead inspector provides the organisation and the inspection team members with an inspection plan or schedule of activities. activities.

GRANTING GLP COMPLIANCE STATUS

Recommendations for GLP compliance status may be:• Unconditional acceptance for GLP compliancestatus;• Acceptance to be deferred until the non-conformances have been addressed;• Rejection of GLP compliance status. Non-confo Non-conformances are generally means for ensuring continual improvement.

GOOD LABORATORY PRACTICE (GLP) COMPLIANCE

The Organisation for Economic Cooperation and Development (OECD) Principles of Good Laboratory Practice (GLP) are applied to the non-clinical safety testing of test items contained in pharmaceutical products, pesticide products, cosmetic products, veterinary drugs as well as food additives, feed veterinary drugs as well as food additives, feed additives and industrial chemicals.

Good Laboratory Practice (GLP) is 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. Nonclinical health and enviNonclinical health and environmental safety studies covered by the principles of GLP include work conducted in the laboratory, in greenhouses, and in the field. In most OECD member countries, legislation requires the application of the principles to all nonclinical health and environmental safety studies for regulatory purposes.

In South Africa, oIn South Africa, organisations voluntarily enter the South African National Accreditation System (SANAS)’s GLP Programme, often to meet international client demands. The Government, through the Department of Trade and Industry and the Department of Agriculture, recognises SANAS in its capacity as National Monitoring Authority for Compliance with the National Monitoring Authority for Compliance with the OECD Principles of GLP.

LEGISLATION

Present legislation governing the assessment, regula-tion and management of chemicals in South Africa in-cludes:• Medicines and Related Substances Control Act, No 101 of 1965 after amendment by the Medicines and Related Substance Control Act of 1997;• Dental Technicians Act, No 197 of 1979;• Plant Improvements Act, No 53 of 1976;• Foodstuffs, Cosmetics and Disinfectants Act, No 54 of 1972;• Agricultural Research Act, No 86 of 1990;•• Hazardous Substances Act, No 15 of 1973;• Fertilizers, Farm Feeds, Agricultural Remedies and Stock Remedies Act, No 36 of 1947.

At present South African legislation does not require regulatory studies to be conducted in accordance with the Principles of GLP.

GLP REQUIREMENTS

Documents and criteria relevant to the OECD Good Laboratory Practice Scheme are as follows:• OECD Principles of Good Laboratory Practic (1997);• • Revised Guides for Compliance Monitoring, Procedures for Good Laboratory Practice (1995);• Revised Guidance for the Conduct of Laboratory, Inspections and Study Audits (1995);• Quality Assurance and GLP (1992);• Compliance of Laboratory Suppliers with GLP Principles (1992);•• The Application of the GLP Principles to Field Studies (1992);• The Application of the GLP Principles to Short-term Studies (1993);• The Role and Responsibilities of the Study Director in GLP Studies (1993);• Guidance for the Preparation of GLP Inspection Reports (1995); Reports (1995);• The Application of the Principles of GLP to Computerised Systems (1995);• The Role and Responsibilities of the Sponsor in the Application of the Principles of GLP (1995);• Requesting and Carrying Out Inspection and Study Audits in another Country (2000);•• The Application of the OECD Principles of GLP to the Organisation and Management of Multi-site Studies (2002);• The Application of the Principles of GLP to in vitro studies;• Establishment and Control of Archives that operate in Compliance with Principles of GLP.

THESE DOCUMENTS ARE THESE DOCUMENTS ARE AVAILABLE FROM:

OECD Environment Directorate Environment, Health and Safety Division Tel: +33 1 4524-8200Fax: +33 1 4524-1675 • E-mail: ehscont@oecd.oFax: +33 1 4524-1675 • E-mail: ehscont@oecd.org http:/www.oecd.org/ehs/glp.html In addition to the OECD Principles of Good Laboratory Practice, GLP compliant facilities are required to adhere to SANAS Document R05 - The Requirements, Obligations and Duties of an Accredited Organisation or GLP Com-plaint Facility.

SANAS is responsible for international liaison on OECDGLP compliance monitoring issues and is committed to meeting the requirements as stipulated in:• Guidance for GLP Monitoring Authorities: Revised Guides for Compliance Monitoring Procedures for Good Laboratory Practice Environment monograph No 110;•• Guidance for GLP Monitoring Authorities: Revised Guidance for the Conduct of Laboratory Inspections and Study Audits – Environment Monograph No 111;• Council Decision concerning the Adherence of Non-member Countries to the Council Acts related to the Mutual Acceptance Data in the Assessment of Data in the Acceptance of Chemicals [C (81) 30 (Final) and C (89) 87(Final) and C (97) 114 (Final].

PROFILE OF INSPECTORS

SANAS is SANAS is responsible for ensuring that an adequate team of inspectors with the necessary technical and scientific expertise, is appointed to carry out inspections. Where necessary, inspectors must be supported by technical ex-perts. SANAS GLP inspectors are required to have a degree or appropriate qualification in Natural Sciences. Candidates should be fully qualified and registered as SANAS lead assessors, befoSANAS lead assessors, before being trained as GLP inspec-tors. Training includes formal courses, observing inspections on study audits conducted by foreign GLP Monitoring Au-thorities and participation in Mutual Joint Visits.

CONFIDENTIALITY

SANAS GLP inspectors and technical experts are required to sign a contract incorporating appropriate confidentiali-ty clauses. GLP Inspectors are provided with positive iden-tification by means of photographs. Technical experts also carry identification, but will always be accompanied on each assignment by a registered SANAS GLP inspector.