How to read and write a quality control report Alongside efficacy and safety, the quality of new and marketed drug products is one of the predominant requirements laid down by the rules governing drug manufacture and approval of new medicines. Quality Control(Drug monitoring): All measures taken, including the setting of specification sampling, testing and analytical clearance, to ensure that raw materials, intermediates, packaging materials and finished pharmaceutical products conform with established specifications for identity, strength, purity and other characteristics. Quality control (QC) has to ensure the constant reproducible characteristics of drugs in all parts of the world in order to guarantee pharmacodynamic effects in all patients. QC plays an important role in exactly elaborating, defining and refining quality specifications and appropriate testing methods. There is a long-established approach to compiling the specifications of pharmaceutical products employing “official” methods including pharmacopoeial methods, validated analytical procedures provided by the manufacturer and approved by the relevant government or validated analytical procedures developed by the laboratory. National pharmaceutical quality control laboratories: The government, normally through the national medicines regulatory authority (NMRA)-in Egypt the ministry of health -must establish a pharmaceutical quality control laboratory to carry out the required tests and assays to verify 1 that pharmaceutical active ingredient, excipients and final products meet the prescribed specifications. Throughout the process of marketing authorization and post marketing surveillance, the laboratory work closely with the NMRA. A national pharmaceutical quality control laboratory: provides effective support for NMRA acting together with its inspection services. The analytical results obtained should accurately describe the properties of the samples assessed, permitting correct conclusions to be drawn about the quality of the samples of medicines analyzed, and also serving as an adequate basis for any subsequent administrative regulations and legal action. The laboratory, or the organization of which it is part, should be an entity that is legally authorized to function and can be held legally responsible. To ensure patient safety, the role of the national pharmaceutical quality control laboratory should be defined in the general pharmaceutical legislation of the country in such a way that the results provided by it can, if necessary, lead to enforcement of the law and legal action. National pharmaceutical quality control laboratories usually encompass essentially two types of activity: 1- Compliance testing of active ingredient, pharmaceutical excipients and pharmaceutical products. 2- Investigative testing of suspicious, illegal, counterfeit substances or products, submitted for examination by medicine inspectors, customs or police. 2 Quality control laboratories of a manufacturer:Each company or factory of pharmaceutical products must establish a quality control laboratory for self inspection and monitoring each product batch before marketing . Marketing authorization (product license, registration certificate): A legal document issued by the competent medicines regulatory authority that authorizes the marketing or distribution of a new pharmaceutical product in the respective country after evaluation for safety, efficacy and quality. In terms of quality it establishes the detailed composition of the pharmaceutical product and the quality requirements for the product and its ingredients. It also includes details of packaging, labeling, storage conditions, shelf-life and approved conditions of use. Quality control report Quality control report is the report presented by the responsible authorities quality control unit at the pharmaceutical product factory or by the quality control laboratory of the ministry of health.Quality control report is considered the passport for any pharmaceutical product to be delivered to the market. Quality control report is written by the responsible pharmacist. The typical structure of the quality control report QC report must contain the following parts:1-The title of the quality control laboratory : a-In case of pharmaceutical product factory : the name of the factory , the name of the unite of drug analysis , the name of the department b-In case of the quality control laboratory of the ministry of health: the name of ministry of health, the name of the 3 unite of drug analysis, the name of the department 2-The address of the quality control laboratory , telephone number(s),fax number,...... 3-The report number. 4-The date of the report. 5-Analytical test report:-(SAMPLE INFORMATION) A-PHYSICAL/VISUAL INSPECTION TEST 1- Labeling requirements:-Brand Name of the drug sample. -Generic name of active ingredient(s). -Dosage form and strength. -Name of reference standard used (as claimed on label e.g. USP, BP, IP, EP). -Manufacturer’s Batch or Lot Number. - Name of manufacturer and address (with telephone and fax numbers). -Manufacturing date. -Expiry date. -Storage conditions. - Registration or licensed number. 2- Sampling requirements:-Name and address (with telephone and fax number, of location/place where sample was collected. -Date when the Lab receives sample. -Name of test requester or sender of the sample/date/sign. 3- Packaging:-Material (blister pack/card, bottle, others specify). -Unit dose per blister card or container stated. -Any print on the packing foil (if packed in blister pack or card). 4-Description of dosage form:4 -Shape (circular, oval, flat sides , liquid , suspension, other) -Uniformity of shape. -Uniformity of color -No physical damage (cracks, breaks, erosion, abrasion, sticky). -Other observations (no foreign contaminant, dirty marks, proper seal - for capsule). B-DISINTEGRATION TEST (IF TESTED) Did the drug pass observed disintegration test? Time of complete disintegration----------- -----C-DISSOLUTION TEST (IF TESTED, SPECIFY METHOD OR PROCEDURE AND ACCPETANCE CRITERIA: ……………………………………………………………………………………… Result: --------------------------------------------------------------------� Passed Failed D-HARDNESS TEST (IF TESTED) Result: -------------------------------------------------------------------- E- OTHER TEST USED FOR VERIFICATION AND IDENTIFICATION OF CONTENT OF ACTIVE INGREDIENT Specify the test method(s) and reference to a pharmacopeial monograph ------------------------------------------------------------------------------------------------------Name of PAI(s):1-………………………………… 2-………………………………….. 5 Identification results: Present--------------------------Not present--------------------- Assay for content Name of PAI (S) 1....................................................... 2........................................................ Acceptance criteria.................................................... …………………………………………………………………. Results---------------------------------------------------------------------------------------------------------------------------------- ---------------------------------------------------------------------- F-FINAL COMMENTS The sample meets standards The sample does not meet standards (Reason:………………………………………………..…… …….) The sample is doubtful for its quality testing (Reason:……………………………….……..…………..……..) and further testing is needed at a reference lab) REPORT PREPARED BY: Date: ………………………………….... Name:……………………………………. Signature: ……………………………… REPORT REVIEWED BY: Date : …………………………………. Name: …………………………………… Signature :…………..…………………… 6 B-ACTION TO BE TAKEN BY THE QC LAB* 1. Report to responsible authorities: Report is writing to e.g. MOH Drug Regulatory Authority : Date and sign………………………… …………………………………… 2.Bureau of Drug and Narcotics Lab. 3. National Institute for Drug Quality Control. Send to: - USP Lab - Send samples to the Reference Lab for confirmatory testing. ( They should always be accompanied by a Request Form) Date:…………………………………………………. Signature:……………………………………………. * Action to be taken and communication between key agencies in the country should be dependent on individual country setting. Exercise:-From your home ,bring a package of any pharmaceutical product. -Make a quality control report for this sample. -Work individually. 7