Laboratory facilities for carrying out analytical tests on products should be available everywhere, ...
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Slide 1:QUALITY ASSURANCE AND THE ROLE OF THE QC LAB
Basic understanding of Quality Assurance and Quality Control
Slide 2:WHAT IS QUALITY?
Dimensions of quality: Performance Features Reliability Conformance Durability Serviceability Aesthetics Perceived quality
Slide 3:WHAT IS QUALITY ASSURANCE (QA)?
“QA is the sum total of all organised arrangements made with the objective of ensuring that medicines are of the quality required for their intended use”.
Slide 4:WHAT ARE THE OBJECTIVES OF QA?
(a) Medicines are designed and developed in such a way that they can be produced to comply with the quality requirements and batch to batch conformity to specifications can be maintained
Slide 5:WHAT ARE THE OBJECTIVES OF QA?
(b) Production operations and Good Manufacturing Practices are clearly specified and adhered to (c) The production environment and services to the production operation are monitored
Slide 6:WHAT ARE THE OBJECTIVES OF QA?
(d) Deviations are adequately recorded, investigated and responded to (e) The supply and use of adequate starting and packaging materials is assured
Slide 7:WHAT ARE THE OBJECTIVES OF QA?
(f) All the necessary controls on intermediate and final products and other in-process controls, validation and, if necessary, trend analysis are carried out
Slide 8:(g) No product is sold or supplied until it is ensured that each batch has been produced and controlled in accordance with legal and other requirements
WHAT ARE THE OBJECTIVES OF QA?
Slide 9:WHAT ARE THE OBJECTIVES OF QA?
h) Medicine are stored, handled and distributed so that quality is maintained throughout their shelf life.
Slide 10:WHAT ARE THE OBJECTIVES OF QA?
(i) The Quality Assurance System is regularly audited by self-inspection for effectiveness and applicability
Slide 11:WHAT ARE THE OBJECTIVES OF QA?
(j) Laboratory operations and Good Laboratory Practices are clearly specified and adhered to
Slide 12:WHAT IS GOOD MANUFATCURING PRACTICE (GMP)?
It is that part of Quality Assurance which ensures that products are consistently produced and controlled to the quality standards appropriate for their intended use and the legal requirements. GMP is thus concerned with both production and quality control matters.
Slide 13:WHAT IS QUALITY CONTROL (QC)?
QC is that part of GMP which is concerned with sampling, specifications and testing, and with the organisation, documentation and release procedures which ensure that the necessary and relevant tests are actually carried out and that materials are not released for use, nor products released for sale or supply, until their quality has been judged to be satisfactory
Slide 14:WHAT ARE THE OBJECTIVES OF QC?
(a) Adequate facilities, trained personnel and approved procedures are available for sampling, inspecting and testing starting materials, packaging materials, intermediates, bulk and finished products, and where appropriate for monitoring environmental conditions for GMP purposes.
Slide 15:WHAT ARE THE OBJECTIVES OF QC?
(b) Samples of starting materials, packaging materials, intermediate products, bulk products and finished products are taken by personnel and by methods approved by Quality Control. (c) Test methods are validated.
Slide 16:WHAT ARE THE OBJECTIVES OF QC?
(d) Adequate standards and reagents are maintained. (e) Records are made, manually and/or by recording instruments, which demonstrate that all the required sampling, inspecting and testing procedures were actually carried out. Any deviations are fully recorded and investigated
Slide 17:WHAT ARE THE OBJECTIVES OF QC?
(f) The finished product complies with all legal requirements and is enclosed within its specified container and correctly labelled.
Slide 18:WHAT ARE THE OBJECTIVES OF QC?
(g) Records are made of the results of inspection and testing of materials, intermediates, bulk and finished products is formally assessed against specification. Product assessment includes a review and evaluation of relevant production documentation and an assessment of deviations from specified procedures.
Slide 19:WHAT ARE THE OBJECTIVES OF QC?
(h) No batch of product is released for sale or supply prior to certification by a qualified pharmacist that it is in accordance with all legal requirements. (i) Sufficient reference samples of starting materials and products are retained to permit future examination of the product if necessary, and the product is retained in its final pack unless exceptionally large packs are produced.
Slide 20:WHAT ARE THE OBJECTIVES OF QC?
(j) Follow-up stability trials in final packaging are conducted to assess the validity of the shelf-life.
Slide 21:“Quite expectedly the problem of stability is more pronounced in developing countries. The reasons are more likely due to extreme climatic conditions, lack of adequate storage facilities and, possibly, suboptimal registration and procurement practices. At the same time, certain countries experience considerable stability problems which may be due to initial quality of the product...” and.. Pharm, 92:180
Slide 22:“... It is recommended that stricter registration procedures for those specific drug products, especially when evaluating data in support of claimed shelf-life.”
Slide 23:REQUIREMENTS FOR THE QC LABORATORY
(a) Designed, equipped, maintained and of sufficient space to perform the required operations (b) Chemical, biological and microbiological laboratories should be separated (c) Equipment and instrumentation appropriate for the testing undertaken
Slide 24:REQUIREMENTS FOR THE QC LABORATORY
(d) Equipment should be serviced and calibrated (e) Written operating instructions for equipment (f) Equipment should be kept clean (g) Staff should wear protective clothing (h) Staff to be well trained and motivated
Slide 25:WHY A LABORATORY?
“Adequate resources must be made available for inspection and enforcement of controls at all stages in the drug distribution chain. Laboratory facilities for carrying out analytical tests on products should be available everywhere, preferably within a national context or, failing this, through regional or international co-operation.” (WHO Information Vol. 6, No. 2, 1992)
Slide 26:IS COUNTERFEITING A REAL PROBLEM?
“Most pharmaceutical companies are unwilling to talk about the problem, because of the danger of scaring the general public. However, the Anti-Counterfeiting Group estimates that the annual loss to drug companies is at least £50 million and up to 70% of all drugs sold in parts of Africa are counterfeit. In Nigeria, eye drops were found that....” Manufacturing Chemist, 1991, Vol. 10, p.21.
Slide 27:IS COUNTERFEITING A REAL PROBLEM?
“Guesstimates of the size of the market in fraudulent medicines range from as high as 50% in the case of Nigeria to a more modest 20-30% in countries like Brazil and Indonesia. These suggest that global sales of fake or spurious medicines could be worth £ 2-4bn a year. The scale of profits make stories of” British Medical Journal, 1992, Vol. 304, p. 334.
Slide 28:IS COUNTERFEITING A REAL PROBLEM?
“The French government has introduces new laws to fight counterfeit drugs-an industry that has an estimated world-wide annual turnover of £6bn ($8,6bn). Counterfeit drugs cost the legitimate pharmaceutical industry an estimated £12bn ($17,3bn) a year.” British Medical Journal, 1993, Vol. 307, p. 130.
Slide 29:IS COUNTERFEITING A REAL PROBLEM?
“The programme builds on a pioneering experiment in Nigeria, financed by a $68 million loan from the World Bank (equal to the country’s annual health budget) when health workers were trained to identify fake or substandard medicines and laboratories established to carry out regular spot checks.” Nature, 1992, Vol 355, p. 192.
Slide 30:US ATTORNEY LOOKS AT 4 NDA FRAUD CASES
“Four cases involving the submission of allegedly false data to the FDA in support of an NDA are under active investigation by the US Attorney’s office, two of them with grand jury status.” Scrip
Slide 31:FDA TO WITHDRAW SUPERPHARM ANDA’S
“The US FDA is proposing to withdraw approval of three ANDA’s held by Superpharm for diazepam because of “untrue statements of material facts ...” Scrip
Slide 32:.... WORLD NEWS IN BRIEF
The Indonesian Health Minister, Dr Adhyatma, has called for increased alertness towards the presence of counterfeit pharmaceuticals in Indonesia. Scrip
Slide 33:WHO IS CENQAM?
Centre for Quality Assurance of Medicines-an independent testing and training centre for the quality screening of pharmaceuticals
Slide 34:PRE-REGISTRATION PHASE
Supportive role Advisory role Erroneous data Miss-interpreted stability data Verification of questionable data
Slide 35:POST-REGISTRATION PHASE
Continuous monitoring Quality profile of medicines on the South African market Investigation of complaints: Product failure Therapeutic inequivalence Bioavailability problems
Causes for product failure Equivalence testing for multi-sourced raw materials
Provide training in: Pharmaceutical analysis Drug quality control QC lab management Post graduate courses and continuing professional development
Implementing of harmonised standards and methods Setting national standards for quality Networking with other countries
Slide 39:NATURE OF LABORATORY SERVICE
Library and literature advice service Compilation of data bank on raw material specifications Access to data bank on drugs already tested for compliance to standards
Slide 40:NATURE OF LABORATORY SERVICE
Laboratory for testing of: Identity Potency Bioavailability Pharmaceutical availability
Slide 41:NATURE OF LABORATORY SERVICE
Access to sophisticated laboratory equipment Training Consulting Collaboration with laboratories world-wide
Slide 42:Stamp out counterfeit
Slide 43:WORK HARD
Slide 44:...AND SEE FIRE WORKS!!