Quality Management
By: Supriya Sharma, Shamita Kohli
Poona College of Pharmacy, Bharati Vidyapeeth University, Pune
Quality should be built into the product & testing alone cannot be relied on to insure product quality. Objectives of quality management are to provide high quality drug product, to prevent the recalls, returned or salvaged products & effective products, harmonize the cGMP to handle many types of changes to help in quality by design, to achieve success in business. Quality management system involves the concepts of quality, quality by design & product development, risk management & risk assessment, corrective & preventive action, quality control & quality assurance. The quality management system is divided into four parts that are management responsibilities, resources, manufacturing operations, evaluation activities.
Quality is effective at every stage of industrial cycle. Quality knows no functional boundaries, quality is everybody’s job & require carefully plan organization wide integration.
The basic concepts of quality assurance, GMP & quality control are interrelated.
Quality Assurance deals with all matter related quality of the product. Quality of a medicine must meet the requirements of the intended used or as required by the customer. It is the sum total of organized arrangement made for producing a quality product.
A pharmaceutical product which meets the five characteristics namely, identity, strength, safety, purity & efficacy can be accepted on a quality product. A system of Q.A appropriate to manufacture of pharmaceutical products should ensure that pharmaceutical products are designed & developed according to GMP, GLP, GVP, GCP etc., production & control operation are clearly specified in a written form & GMP requirements are adopted, managerial responsibilities are clearly specified in job descriptions, arrangements are made for manufacture supply & use of correct starting & packaging materials, all necessary control on starting material, intermediate products & bulk products & other in process controls, calibrations & validation are carried out, the finished product is correctly processed & checked, according to defined procedures, pharmaceutical products are not sold before the authorized persons have certified that each production batch has been produced & controlled in accordance with the requirements of the marketing authorization, satisfactory arrangements exist to ensure, as on far as on possible, that the pharmaceutical products are stored by the manufacturer, distributed and subsequently handled so that quality is maintained throughout their shelf life, there is a procedure of self inspection &/or quality audit that regularly appraise the effectiveness of the Q.A. system, production environment and service to production operations are monitored, and deviation should be adequately recorded, investigated & responded. The company should have documents for Quality Policy.
Good Manufacturing Practices is a part of Q.A. whose main function is to produce quality product consistently. Main function of GMP is to diminish the risks of mix-ups & contaminations. The activities of GMP involves clear defining of all manufacturing processes, validation of critical steps of manufacturing processes and any significant changes made to them, arrangement of all necessary facilities, production department should manage to arrange adequate personnel, laboratories & equipment in IPQC, writing all the instructions and procedures in clear and unambiguous language, training of operators to carry out procedures correctly.
Q.C. is a part of GMP. It deals with sampling, specifications & testing, documentation & release procedures. Q.C ensures that the necessary & relevant test are actually carried out & that materials are not released for use, nor products released for sale or supply, unless their quality is satisfactory. Q.C. should be independent of production department.
Q.C. department should have adequate facilities, trained personnel & approved procedures must be available for sampling, inspecting & testing of starting materials, packaging materials & intermediate bulk & finished products & where appropriate for monitoring environmental conditions for GMP purpose. There should be written SOP for sampling for RM/PM/Int. & finished products. The method for sampling, testing and other activities must be validated. Records must be made for sampling and testing activities.
Sampling activities get lot of attention of all the regulatory authorities. Sampling should be representative of the batches of materials from which they are taken.. Care should be taken during sampling to guard against contamination or mix-ups of or by the material being sampled. Sampling equipment should be cleaned. Documents like SOP for sampling are required. Sampling & dispensing of sterile materials shall be conducted under aseptic conditions confirming to Grade-A.
Reference sample means a representative sample of a substance used in the manufacture of a product. Major guiding principles states that retention samples from each batch of finished product should be kept for at least one year after the expiry date in their final packaging & stored under the recommended conditions.
SOP should be prepared for sampling of IPQC the materials & their testing. Parameters to be considered which are responsible for causing variability in the characteristics of the in-process materials & the drug product are selected. What specifications should be met at each critical stage of manufacturing should be identified & limits should be defined.
Testing of materials involves testing of active & inactive pharmaceutical ingredients, primary, secondary & other packaging material, in-process materials, finished bulk product, finished packed product.
Reference standards, any secondary standards prepared from them & purchased reagent should be dated where necessary & be stored, handled & used following written SOP procedures.
After the batch of a finished pharmaceutical is packed, certain quality of samples is kept aside for future & should be kept for at least one year after the expiry date of the finished product.
A written record of the investigation should be made & should include the conclusion & follow-up action.
Stability studies of a finished pharmaceuticals is an important activity under quality system. Documents showing that the stability studies are carried out for each products being manufactured, are required by regulatory authorities. Documents like SOP/R on stability studies are required.
Self-inspection is carried out to evaluate the manufacturers compliance with G.M.P. in all aspects of production & quality control. The self inspection SOP should cover items for self inspection, self inspection team, frequency o self inspection, self inspection report and follow-up action.
Quality audit may be defined as an examination & assessment of all parts of a quality system with a specific purpose of improving it. A quality audit is usually conducted by outside or independent specialists or a team designated by the management for this purpose. Such audits may also be extended to suppliers & contractors.
Documents like SOP/R on self inspection, quality audit & supplier audit are required.
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Current Good Manufacturing Practices 