Quality Assurance is a wide ranging concept covering all matters that individually or collectively influence the quality of product. “ It is the totality of the arrangement made with the object of ensuring that pharmaceutical products are of the quality required for their intended use” QA is the heart and soul of the quality control. QA=GCP + GLP + GPP + GMP + any other measure to achieve intended quality.
Pharmaceutical products are designed and developed in a way that takes account of the requirement of GMP and other associated codes such as those of good laboratory practice (GLP) and good clinical practice (GCP) Product and control operations are clearly specified in a written form and GMP requirements are adapted. Managerial responsibilities are clearly specified in job descriptions.
Arrangements are made for the manufacture, Supply and useof correct starting and packaging material.All necessary controls on starting material, intermediateproducts and bulk products and other in process controls,calibrations , and validation are carried out.The finished product is correctly proceed and checkedaccording to the defined procedure.Pharmaceutical products are not sold or supplied before theauthorized persons have certified that each productions batchhas been produced and controlled in accordance with therequirement of the marketing authorization and any otherregulations relevant to the productions, control and release ofPharmaceutical products.
Satisfactory arrangements exist to ensure, as far as possible,that the pharmaceutical products are stored by themanufacture, distributed and sub-sequent handled so thatQuality is maintained throughout their shelf life.There is a procedure for self inspection and/or quality auditthat regularly appraises the effectiveness and applicability ofthe QA system.
Quality Assurance is independence of manufacturing. In process quality is checked during manufacturing. Validation of facilities, Equipment , Process ,Products and cleaning as per master plan. Compliant handling. Storage of Quality record and control samples. Stability studies. Registration documents
1. Technology transfer2. Validation3. Documentation4. Quality Improvement plans5. Assuring Quality of the Products
1. Technology transfer Receipt of product design documents from research centre. Distribution of documents received from the research centre. Checking and approval of documents generated based on research centre document. i.e. batch manufacturing records. Scale up and validation of product.
2.Validation:Preparation of Validation plans for facility,equipments/process including cleaning.Approval of protocol for Validation of facility/equipments/product/process.Team member for execution of validation of facility/equipments/product/process
3. Documentation control: Control distribution and achieving of documents. Control of changes made by proper change control procedure. Approval of document.
4. Quality Improvement plans: Feedback received from the compliance team Proposals for corrective and preventive actions Annual products review Trend analysis of various quality parameter for products , environment and water.
5. Assuring Quality of the Products: CGMP training SOP compliance Audit of facility for compliance Line clearance In-process counter checks Critical sampling Record verification. Release of batch for marketing Investigation of market complaints
“Good Manufacturing Practice is that part ofquality assurance which ensures that productsare consistently produced and controlled to thequality standards appropriate to their intendeduse and as required by the marketingauthorization”
GMP is aimed primarily at diminishing the risks inherent inany pharmaceuticals production.Such risks are essentially of two types:(1)Cross contamination (in particular of unexpectedcontaminants)(2)Mix-ups (confusion Caused by, for example, false labelsbeing put on containers.
All manufacturing process are clearly defined Qualifications and validation are performed All necessary resources are provided (1) Appropriately qualified and trained personnel; (2) Adequate premises and space; (3) Suitable equipment and services; (4) Appropriate materials, containers and labels; (5) approved procedures and instructions; (6) Suitable storage and transport; (7) Adequate personnel, laboratories and equipment for in process controls;
Instructions and procedures are written Operators are trained to carried out procedure correctly Records are made Storage and Distribution Recall Complaints
Conformance to the predetermined specifications To eliminate errors To improve efficiency To reduce costs To prevent risks To minimize contamination To produce product of consistent quality
“A quality system concerned with theorganizational process and the conditionsunder which non-clinical health andenvironmental safety studies are planned,performed, monitored, recorded, archived andreported.”
To promote the development of quality test data and to provide a managerial tool to ensure a sound approach to the management Set of criteria to be satisfied as a basis To allocate roles and responsibilities in order to improvement To focus on those aspects of study excretion
The GLP principles in their strict, regulatory senseapply only to such studies on pharmaceuticals which: Are non-clinical, i.e. are mostly conducted in animals or in vitro, and include analytical aspects. Are conceived to obtain data on the properties and/or safety with respect to human health and/or the environment of the testing substances. Are intended to be submitted to a national registration authority for the purposes of registering or licensing the tested substance or any product derived from it.
In general and depending upon national legal requirements, the GLP requirements for non- clinical laboratory studies conducted for the safety evaluation in the field of drug safety testing cover the following classes of studies: Single dose toxicity. Repeated dose toxicity (sub-acute and chronic). Reproductive toxicity (fertility, embryo-foetal toxicity and teratogenicity, perinatal /postnatal toxicity). Mutagenic potential.
Carcinogenic potential. Toxicokinetics (pharmacokinetic studies which provide systemic exposure data for the above studies). Pharmacokinetic studies designed to test the potential for adverse effects (safety pharmacology). Local tolerance studies, including photo toxicity, irritation and sensitization studies, and testing for suspected addictively and/or withdrawal effects of drug.
Apply to the relevant studies planned and conducted in a manufacturer’s laboratories Strict adherence to GLP will remove many sources of error and uncertainty The requirement to formulate a study plan with a defined purpose of study will prevent false starts and diminish the incidence of incomplete or inconclusive studies. Respecting the GLP principles will thus indirectly optimize the scientific yield of such studies.
Annex 4 GMP for pharmaceutical products, WHO Guidelines GLP , Handbook of GLP, Quality practices for regulated non clinical research and development How to practice GMPs 4th Edition By P.P. Sharma. How to practice GLP By P.P.sharma , Vandana Publication.