Quality control managment

QCM, quality control managment

1. INTRODUCTION TO QUALITY CONTROL MANAGMENT PRESENTED BY DR. QURESHI JALIB

2. QUALITY MANAGEMENT SYSTEM QMS is the set of policies , processes and procedures required for planning and execution (production/development/services) in the core business of an organization’s. (area that cant impact the organization’s ability to meet customer requirements.

3. QUALITY MANAGMENT Activities performed to formulate and implement policies and programs intended to achieve quality. It ensures that an organization ,product, service is consistent. It has four main components: Quality planning Quality assurance Quality control Quality improvement

4. It is focused not only on product and service quality but also on mean to achieve it. QM uses quality assurance and control of processes as well as product to achieve more consistent quality.

5. QUALITY PLANNING Identifying which quality standards are relevant to the project and determining how to satisfy them. INPUT:- ENVIRONMENTAL FACTORS QUALITY POLICY PROJECT SCOPE STATEMENT STANDARDS AND REGULATION

6. TOOL:- cost benefit analysis design of experiment cost of quality FLOW CHARTING OUTPUT:- QM plan, quality metrics process improvement plan

7. QUALITY ASSURANCE Application of planned , systematic, quality activities to ensure that the project will employ all processes needed to meet requirement. INPUT:- QMP, process improvement plan work performance info. quality control measurements, implemented corrective actions, implemented defect repair, implemented preventive actions.

8. TOOL: QUALITY PLANING TOOLS QUALITY AUDITS PROCESS AN ALYSIS OUTPUTS:- QUALITY IMPROVEMET.

9. QUALITY CONTROL Monitoring specific project results to determine whether they comply with relevant quality standard and identifying ways to eliminate cause of unsatisfying results. INPUTS:- QMP WORK PERFORMANCE INFO. APPROVED CHANGE REQUEST

10. TOOLS:- CONTROL CHARTS FLOW CHARTS HISTOGRAM STATISTICAL SAMPLING INSPECTION OUTPUTS:- QUALITY IMPROVEMENT ACCEPTANCE DECISION REWORK COMPLETED CHECKLIST PROCESS ADJUSTMENT

11. GENERAL PRINCIPLES QC in pharmaceutical industry is the effort to design the requisite specification and to produce and assure the consistent attainment of those specification in its finished product. Effectiveness of principles and standard are determined by continued product acceptance.

12. Purpose of quality control is to help establish those characteristics and to validate conformance of product to those characteristics. Goal of QC in industry: Achievement of specification Insure Product acceptance Assure compliance

13. QUALITY CHARACTER EVALUATION Sampling Identification Testing Stability Based on final product’s intended use.

14. TESTING Organoleptic Chemical Physical Biological Microbiological Must be sufficiently specific and accurate to assure that each material is subjected to meaningful tests and results are reliable.

15. Auditing control system and evaluation of material and final product --------responsibility of QC dpt. Approval or rejection by executive of QC dpt.

16. VALIDATION Documenting that a process or system meets its pre-determined specifications and quality attributes. Scientific demonstration by appropriate test. Validation responsibility----------QC, R&D, MANUF. Maintained by QC for factory inspection. Incorporated in master file. Production operating instruction for product.

17. DOSAGE FORM CONTROL GMPs Specification Sampling procedures Process control Stability is reconfirmed on marketed package over period of its expected shelf life.

18. PROCESS CONTROL QA in pharmaceutical company provides surveillance of many phases of production. TESTING PROGRAM AND METHOD QA certify that each batch meets established standards. Physical , chemical, biological testing.

19. SPECIFICATIONS Purpose is to ensure that characteristics of finished product conform to appropriate standards of Identity Purity Potency Quality Therapeutic activity Are designed to test the product quality consisting of series of method.

20. Used in procurement of: Drug substance Excipients Reagents Packaging material Printing material Incoming material and finished products are checked against these specifications.

21. STANDARDIZATION OF PHARMACEUTICAL CHEMICALS AND FORMULATED PRODUCT

22. OFFICIAL STANDARDS Designed to set permissive limit of tolerance for product at time it reaches the patient. Specification + degradation up to shelf life. ENCOMPASSES Methods of manufacture Safety against different standards of purity Impurity patterns Varying degree of stability

23. Prime consideration is that product should be satisfactory clinically. Reasonably reproducible product prepare in diff. labs. Ensures that product retains acceptable level of potency and freedom from toxicity during storage before use.

24. MANUFACTURING VARIATIONS The principle hazard is loss of active ingredient. Standards allow for unavoidable decomposition or loss in manufacture and storage under reasonably adequate condition for a reasonable period of time.

25. OFFICIAL METHODS OF CONTROL Official monographs for pharmaceutical chemicals and finished products are available in official book U.S.P , N.F , B.P. , and other. GENERALLY INCLUDES Description of drug Test for identity Physical constants Quantitative assay of active constituents Limit test for contamination Storage conditions

26. U.S.P monograph on solid dosage form include Description of dosage form Pharmaceutical group Dose or dose range Strength available Dispensing information Assay and tolerance Packaging and storage Disintegration time Weight variation Content uniformity Dissolution test

27. INFORMATION ON INJECTIBLES INCLUDE Size available Description of composition Assay tolerance Packaging and storage Labeling and whether IM or IV Potency Pyrogen test Clarity test Sterility test pH

28. ASSAY Procedures describes under official monograph. Assay for pure chemical is simple than finished form. ASSAY TOLERANCE Limits of error of actual assay process for AI, manuf. Tolerances for dosage form, sampling error.

29. SAMPLING PROCEDURE AND ERROR Error due to sampling arise in the selection of material for analysis where the material selected is not truly representative of batch as whole. METHOD Bulk is divided in units and equal size of each unit is taken randomly. Crude drugs, sample collected randomly in proportion to amount of that material present in whole

30. SAMPLING ERROR Difference b/w mean value of AI in sample and true value. SAMPLING AFTER PACKING CONTAINERS ---------- RANDOM SELECTION SEMI-SOLID ------------ shake or stirred

31. UNIT DOSE VARIATION Products such as injection, tablets, capsules, powders are supplied in unit dosage form are subjected to great variation. Standard applied are Uniformity of weight Uniformity of diameter Uniformity of volume Content of active ingredient Uniformity of content