QCM, quality control managment

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

3. 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.

4. 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

5. • 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.

6. 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

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

8. 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.
•

9. • TOOL:
–QUALITY PLANING TOOLS
–QUALITY AUDITS
–PROCESS ANALYSIS
• OUTPUTS:-
–QUALITY IMPROVEMET.

10. 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

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

12. 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.

13. • 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

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

15. 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.

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

17. 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.

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

19. 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.

20. 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.

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

22. STANDARDIZATION OF PHARMACEUTICAL
CHEMICALS AND FORMULATED
PRODUCT

23. 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

24. • 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.

25. 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.

26. 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

27. • 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

28. • 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

29. 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.

30. 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

31. 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

32. 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