Important informations Good manufacturing practice (GMP) & Quality Assurance (QA) & Quality control (QC)

Quality ● Quality must be built into a drug product and process design and it is influenced by the physical plant design, space ventilation, cleanliness and sanitation during routine production. ● The quality in the pharmaceutical industry represents both function and process (many things to many people) Function: There are operational groups whose major responsibilities are to assure quality creation and maintenance "The quality assurance department " To monitor the specifications established to control activities " The quality control department " Process: Refers to that set of activities and operations which determine whether a pharmaceutical product has quality.

QA & GMP & QC inter-relationship It is the sum total of the organized arrangements with the objective of ensuring that products will be of the quality required for their intended use

Quality assurance  Is a wide-ranging concept covering all matters that individually or collectively influence the quality of a product.  Manufacturing and marketing of safe effective products of the highest quality is the main objective of quality assurance.  Quality assurance therefore, incorporate both GMP, quality control and other factors such as product design.

QC Part of GMP concerned with sampling, specification & testing, documentation & release procedures which ensure that the necessary & relevant tests are performed & the product is released for use only after ascertaining it’s quality

GMP Is that part of QA aimed at ensuring that products are consistently manufactured to a quality appropriate to their intended use

Good manufacturing practice GMP  It is, thus concerned with both manufacturing and quality control procedures.  It is the concept that covers the assurance of safety and effectiveness of pharmaceuticals during all stages of manufacturing.  GMP recognized for control and management of manufacturing and quality of pharmaceutical product.

GMP ● GMP is a part of QA which ensures that products are consistently produced & controlled to the quality standards appropriate to their use. ● QC is a part of GMP It is concerned with: Sampling, specifications, for raw material, consumables and finished product, testing documentation, release product, analytical equipments and good laboratory practice.

 GMP ensures that quality is built into the organization & processes involved in manufacture.  GMP covers all aspects of manufacture including collection, transportation, processing, storage, QC & delivery of the finished product

QC & QA  QA is the sum total of organized arrangements made with the object of ensuring that product will be of the Quality required by their intended use.  All those planned or systematic actions necessary to provide adequate confidence that a product will satisfy the requirements for quality.  QA is company based.  Part of GMP which is concerned with sampling, specifications, testing and with in the organization, documentation and release procedures which ensure that the necessary & relevant tests are carried out.  Operational laboratory techniques & activities used to fulfill the requirement of Quality.  QC is laboratory based.

QUALITY RELATIONSHIP QA GMP QC Quality management aspects (policy) Quality system (organizational structure) QA Quality assurance (confidence to the management) GMP QC GMP Quality control (operational technique and activities)

What is quality management?  QM is defined by world health organization (WHO) as the "aspect of management functions that determines and implements the quality policy″. It is the overall intention and direction of an organization regarding quality as formally expressed and authorized by top management.  Under QM, the manufacturer is obliged to assume responsibility for the quality of the pharmaceutical products to ensure that they are fit for their intended use, comply with the requirements of the marketing authorization, and do not place the patient at risk because of inadequate safety, quality and efficacy.

BASIC DUTIES OF QA ● Ensure that products are designed and developed based on sound scientific rationale and with GMP or GLP principles being taken into consideration. ● Ensure that managerial responsibilities are clearly specified. ● Ensure that production and control operations are clearly specified in a written form and GMP is adopted. ● Organize supply & use of correct starting & packaging materials. ● Ensure that finished products are correctly processed & checked before release. ● Ensure that products are released after review by authorized person. ● Provide satisfactory arrangement to ensure that products are stored, distributed & handled appropriately. ● Put in place a mechanism for regular self inspection / internal quality audit. ● All necessary controls on starting materials, intermediate products and bulk products and their in-process controls, calibrations and validations are carried out.

Quality control Manufacturer should have a QC department.  QC is part of GMP.  QC is concerned with sampling, specification and testing. Manufacturer should have a QC department.  QC should be headed by an appropriately qualified and experienced person.  QC should be independent from production and other departments.  Ensure that the necessary and relevant tests are actually carried out.  Ensure that no materials or products will be released for sale or supply, until their quality have been evaluated and judged to be satisfactory.

Scope of the quality control Items concerned are  Starting materials  Packaging materials  Bulk products  Intermediate and finished products  Environmental conditions

Basic requirements of quality control  Adequate facilities, trained personnel and approved procedures should be available for sampling, inspecting and testing and, where appropriate, environment monitoring.  Sampling by QC personnel & testing by approved methods.  Maintenance of QC records & failure investigation records.  Ingredients comply with regulatory specification (grade, composition, strength).  Review and evaluation of production documentation.  Assessment of process deviations.  Release of batches by authorized person.  Sufficient reference samples of starting materials and finished products.

Quality control activities QC should cover the following: 1. Sampling 2. Specification 3. Testing 4. Release procedures 5. Recalls and complaints 6. Decision making in all quality matters 7. Definition of product quality 8. Laboratory operations 9. Release authorization 10. Investigation and reporting

Other duties of quality control  Establish QC procedures  Manage reference standards  Ensure correct labeling  Stability testing (if applicable)  Complaint investigation  Environmental monitoring

Summary Responsibility of quality control Quality control have the responsibility and authority to accept or reject: 1) specification of all components, product container and closure, in‐process materials, labeling and packaging materials and finished drug product. 2) design and engineering of physical facilities, equipment, tools and apparatus.

Summary Responsibility of quality control (Continued ) 3) background of education, training, and experience of all personnel. 4) carrying the tests for incoming raw materials, in-process materials and finished product. 5) Release all the procedures and documents. 6) Handle compliance.