Quality & GMP Presentation

1. QC Department: Quality Objectives & GMP ajmal lab ( dhak )

2. Quality control Quality control  (QC) is a procedure (s) intended to ensure that a manufactured product or performed service adheres to a defined set of  quality  criteria or meets the requirements of the client or customer. It is a combination of all the characteristics of a product that determine the degree of acceptability of the product. QC is similar to, but not identical with,  quality assurance  (QA).

3. Quality control Versus Quality assurance The terms often used interchangeably to refer to ways of ensuring the quality of a service or product . Quality Assurance:  The planned and systematic activities implemented in a quality system so that quality requirements for a product or service will be fulfilled . Quality Control:  The observation techniques and activities used to fulfill requirements for quality .   An evaluation to indicate needed corrective responses; the act of guiding a process in which variability is attributable to a constant system of chance cause s.

4. Quality control Versus Quality assurance QA is a  failure prevention system  that predicts almost everything about product safety, quality standards and legality. QA department  develops  all the planning processes QA  defines  the standards/methodology to be followed in order to meet the customer requirements.  QA  activities are done before  the product is manufactured or the service delivered (proactive approach). QA is  process  oriented. QA  makes sure  you are doing the right things, the right way. QC is a  failure detection system  that uses a testing technique to identify errors or flaws in products and tests the end products at specified intervals. Follows up on the QA’s action QC  ensures  that the defined standards are followed at every step. QC  activities are done during  the manufacturing process and once the product is manufactured. QC is  product  oriented. QC  makes sure  the results of what you've done are what you expected. QA QC

5. Introduction to GMP Good manufacturing practice (GMP) is a system for ensuring that products are consistently produced and controlled according to quality standards. It is designed to minimize the risks involved in any pharmaceutical production that cannot be eliminated through testing the final product. BASIC FUNDAMENTALS INCLUDES Control Quality Safety Effectiveness,

6. GMP GMP covers all aspects of production, including; Personnel Premises Equipment Starting materials Production & In-process control Laboratory Control Packaging & Labeling Holding & distribution (ware house) Documentation: There must be systems to provide documented proof that correct procedures are consistently followed at each step in the manufacturing process - every time a product is made . :   

7. Why is GMP important?  Avoids poor quality medicines, a health hazard Saves waste of money for both government and individual consumers . Helps boost pharmaceutical export opportunities Reduces and prevents errors Prevents contamination & cross contamination Minimizes variance in drug potency Prevents toxicity Prevents mislabeling Avoids adulteration    

8. Organization and personnel Lay out of clean rooms Wear clean clothing Wear protective apparel to prevent contamination Practice good sanitation If sick or have open lesions that would impact the drug, excluded from direct contact with the product Regular medical check-ups

9. Building and Facilities Building will be adequately sized for proper storage of equipment and material Operations will be performed in specific areas Raw materials received will be placed in quarantine until tested Rejected material will be separated A dequate lighting A dequate environmental controls A ir breaks on drains

10. EQUIPMENTS M aintained in a good state & qualified (Design, Cleanliness, Installation, Performance) Placed in appropriate place ( temperature & humidity control) W ill be cleaned with approved cleaning agents will not affect product written schedule of cleaning clean after each batch ID number on equipment

11. Starting MATERIAL Received in Quarantine not used until released Written procedures on receipt, handling and sampling Stored off the floor Each container marked with lot number, name and status (released, quarantined, rejected)

12. PROCESS CONTROL There will be written procedures Document activities batch record log books Work Instruction & operating procedures Control contamination Line clearance & Cleanliness & tanks, paddles, piping, probes, etc. Keep organized

13. WARE HOUSE It shall be clean Sections clearly identified: quarantine - yellow released - green rejected - red FIFO: First In - First Out Track inventory and sold lots

14. PACKAGING AND LABELLING The written display on the container Document receiving Separate labeling to avoid mix up Set procedures for appropriate: Identity Storage Handling Sampling Testing Inspection prior to issuance Label control begins with design

15. QC LAB H ave specifications, standards, sampling plans, test procedures Shall have a calibration and maintenance program written with a time period for performance Document all testing use logbooks Stability testing done Reserve samples will be kept for final products over the period of the expiration date

16. DOCCUMENTATION Records maintained batch records testing investigations training maintenance Cleaning If it was not documented, then it did not happen!

17. DUTIES OF H.O.D Authorization of written procedures Control & Monitoring Process validation Calibration of analytical apparatus Plant hygiene Training Retention of records Monitoring of compliance of GMP Inspection and investigation to assure quality

18. Duties of Production Incharge To ensure following: Product produced, stored and documented as per quality Approve instruction for production operations & strict implementation Evaluation of production records and its availability to QC Check maintenance of department, premises and equipments Ensure process validation Training

19. Duties of QUALITY CONTROL INCHARGE To approve, reject the starting material, packaging material, intermediate, bulk and finished good. Evaluate batch record Approve sampling instruction Ensure necessary testing Check maintenance of department, premises and equipment To ensure training of other QC personnel’s

20. Objectives & KPI’s OBJECTIVES    100% compliance of Drug Rules and GMP Make and execute each category of product standard New products every year KPI’s Product standards GMP compliance BMR, Batch records, Test reports Minimal non-conformity No. of Projects to improve Quality