A SEMINAR ON GOOD MANUFACTURING PRACTICES FOR ORGANIZATION AND PERSONNELGUIDED BY: PRESENTED BY:Mr. Moin K. Modasiya Hitiksha Kanani M.PHARM (Q.A.) SEM - 1 APMC College Of Pharmaceutical Education And Research, Motipura, Himatnagar
CONTENTS ORGANIZATION Introduction Responsibilities Authorities PERSONNEL Objectives Principle General Key personnel Qualification of personnel Different stages of training Personnel responsibilities Personnel hygiene 2
ORGANIZATIONCompliance Policies and Standards Audit (Internal and External). Regulatory Commitments and Documents. Recall. In the above model, the three groups typically report to one quality head or leader. The activities and responsibilities in QA and compliance can vary, and in smaller organizations, there may be only a QA and QC organization. QC: All inspection & testing. QA: All systems and procedures including batch review and audit. 3
ORGANIZATION ROLE OF QA AND QC UNITS : QA role is critical because of gaining importance with increased reliance on non-QC personnel for quality related activity such as in-process control and customer complaint co-ordination. QC should be a resource that plays a positive role in improving profitability. More effective approaches should be as following : Design quality during development phase. Subsequently adding additional assurance during production. New product –developed by R&D team they should provide draft with appropriate specifications then, reviewed & approved by QC. 4
ORGANIZATIONReporting Can not report to the person directly accountable for the production. This creates pressure on production.In some companies:1. Reporting to the group QC function/ scientific / technical function.2. Reporting to plant manager provides. This gives an added degree of independence. Quality can not be achieved by police approach.Ideal:Entire plant operate as a quality-aware team.Every person should perform his job to achieve standards.With independent QC,responsibility is divided for production& QC. 5
ORGANIZATIONAuthority & Responsibility of QC To reject or approve All components; Drug product containers; Closures; In-process materials; Packaging materials; Labeling; Drug products; to review production records to assure that no errors have occurred. Availability of adequate laboratory facilities for (all in one). Responsibility (Authority): Approve all procedures and specifications impacting on identification, strength, quality and purity of the drug product. Responsibilities and procedures as written procedures. 6
PERSONNELObjectives: To review general issues related to personnel. To review requirements for key personnel. To review the training of personnel. To consider some specific issues.
PERSONNELPrinciple: Establishment and maintenance of satisfactory system of QA, manufacture and control of products and active ingredients rely on people. Must be sufficient qualified personnel to carry out tasks. Individual responsibilities must be clearly defined and understood by individuals concerned. Written job descriptions and all personnel should be aware of the principles of GMP that affect them.
PERSONNELGeneral (a):Personnel requirements: Adequate number of persons. With necessary qualifications. With practical experience. An individual’s responsibilities should not be so extensive as to present a risk to quality.
PERSONNELGeneral (b): All responsible staff should have specific duties recorded in individual written job descriptions. Have adequate authority to carry out responsibilities. May delegate to designated deputies with qualifications. No gaps or unexplained overlaps. Organization chart.
PERSONNELGeneral (c): All personnel should be aware of GMP. Must receive training in GMP: Initial training. Continuing training. Including hygiene standards. Motivated to Support the establishment. Maintain high-quality standards.
PERSONNELKey Personnel: Key personnel (which normally should be full-time) positions include: Authorized person. Head of Production. Head of Quality Control. May delegate functions – not responsibility. Heads of Production and Quality Control should be independent of each other.
PERSONNELHead of Production: Responsibilities Product production and storage according to appropriate documentation. Approval and implementation of production instructions, in-process QC and ensure strict implementation. Ensures that production records are evaluated and signed by designated person. Checks maintenance of production department, premises and equipment. Ensures initial and continuous training of production personnel.
PERSONNELHead of Quality Control: Responsibilities Approval or rejection of materials, e.g. packaging materials, intermediates, bulk and finished products, in accordance with specifications. Evaluation of batch records. Ensures carrying out of necessary testing. Approval of quality control procedures, e.g. sampling and testing; specifications. Approval and monitoring of all contract analysis. Ensures validation (including analytical procedure validation) and calibration of control equipment.
PERSONNELAuthorized person: Responsibilities Oversight of the QC department. Participation in external audits and vendor audits. Participation in validation programmes. May delegate approval of release of product through approved procedure. Normally by QA by means of batch review.
PERSONNELQualifications:Should posses appropriate qualifications. Scientific education such as: Chemistry or biochemistry; chemical engineering; microbiology; pharmaceutical sciences and technology; pharmacology and toxicology; physiology; or other related science subjects relevant to the responsibilities to be undertaken.
PERSONNELShould posses appropriate experience Practical experience Manufacture and quality assurance. Preparatory period under professional guidance sometimes needed. Education and experience should enable personnel to take difficult decisions in an independent, professional and scientific way Resolve the problems encountered in manufacturing and QC.
TRAININGAt all levels a developing and continuous process whereperformance and appraisal.FDA (cGMP): no definition of education qualification, experience,skill, knowledge.However, European and WHO guidelines specify educationqualification ,experience, skill, and knowledge both production andquality.Initial screeningSelection of persons with basic skills Reading: to follow written procedure; Writing: for recording atypical situations; Numeracy: for statistical process controls; No color vision problem. 19
TRAINING & DEVELOPMENT CYCLE Basic Position Applicant Induction training requirements screening training defined Evaluation & appraisal New position Additional /retraining 20
TRAINING INDIAN GMPTraining programmed include: Principles of GMP and Principles of GLP. Duties & responsibilities of different personnel. Cleanliness, general hygiene, personal Cleanliness, and health. Characteristics of pharmaceuticals , handling & dangers. First aid and Fire fighting & other safety measures. Topics like behavioral sciences. 21
TRAININGAppropriate evaluation steps are required at the end of eachmodule followed by appraisal ( to confirm the learned lessons areput into practice).Repetition of training is required if necessary.Regular evaluation / appraisal decides that level of employee. Further need of training or to meet the changing needs of the situation or preparation for a new job. Training is under handling of departmental management. Training records must be maintained. Review of training content & records is also needed. 22
PERSONNEL RESPONSIBILITIES Related to personnel hygieneAny person engaged in following jobs like Manufacturing ; Processing ; Packaging ; Holding of a drug ; should wear clean clothing.Protective apparelLimited access areas : restricted movements.Illness/ any visible lesions: affect the quality of the product such persons are excluded from direct contact with components, drug product containers, closures, in-process materials.All persons : report to supervising personnel.Appropriate clothing : considering the end purpose of quality of product. 23
PERSONNEL RESPONSIBILITIESWearing plant uniforms: satisfactoryGuidelines Sufficient amount of clean uniforms: frequency of clean. Checking washing and sanitation processes for effectiveness. Special Clean areas: wear only lint free garments. Designing & type of clothing: for maximum comfort. Range of clothing: 1. Hats/hair cover; 2. Coveralls; 3. Disposable gloves; 4. Foot cover; 5. Masks; 6. Safety glasses/goggles; 24
PERSONNEL HYGIENEMedical history:Pre employment medical examination is required.Chest X-ray, Wassermann test, tuberculosis test, periodic eye test.Fitness certificate is necessary after illness.Annual medical examination of personnel is also required.Main Objective: To protect the product from personnel and particulate matter. To prevent contamination.Consultants: advising, sufficient education, experience,Records are to be maintained. 25
REFERENCES Willig H. Sidney, Stoker R. James; “Good manufacturing practices for pharmaceuticals”, Marcel Dekker series Volume-78, Fourth edition, p.p. 23-31. P.P. Sharma; “How to practice GMPs”, Vandana Publication, Fourth edition,p.p.149-160. http://pharmatips.doyouknow.in/Articles/Quality- Assurance/GMP/GMP-Organization-And- Personnel.aspx 26