SELF INSPECTION & QUALITY AUDIT

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SELF INSPECTION & QUALITY AUDIT PROPOSED BY GMP REGARDING MAINTENANCE OF EQUIPMENT OF PHARMA MANUFACTURING UNIT.:

GUIDED BY: MRS. NIKITA PATEL MRS. LALIT LATA JHA PREPARED BY: CHARMI PATEL M.PHARM-QA SELF INSPECTION & QUALITY AUDIT PROPOSED BY GMP REGARDING MAINTENANCE OF EQUIPMENT OF PHARMA MANUFACTURING UNIT. 1

CONTENTS:

Definition Objectives of self-inspection Principle of self-inspection Types of self-inspection Self-inspection team Frequency of inspection Items of self-inspection Carrying out self-inspection Quality audit Review of documents Checklist of inspection on equipments 2 CONTENTS

CONT…:

Equipment - design & construction - installation & location - cleaning & maintenance Documents required in self-inspection 3 CONT…

PowerPoint Presentation:

SELF INSPECTION consists of a periodic detailed examination of conditions and working procedures by a team from the production site, with the aim of  verifying that good pharmaceutical manufacturing practices are being applied and to propose any necessary corrective measures to responsible management. QUALITY AUDIT consists of an examination and an evaluation of all or part of a system of quality assurance. It must be carried out by a specialist or a team designated for this purpose. It may be extended, as necessary, to suppliers and sub-contractors. 4

OBJECTIVES OF SELF-INSPECTION:

To identify the role of self-inspection in the quality management system To review the way in which a self-inspection programme should be carried out To discuss what to inspect and verify in a company’s self-inspection system OBJECTIVES OF SELF-INSPECTION 5

PRINCIPLE OF SELF-INSPECTION:

Purpose of self-inspection is to evaluate whether a company’s operations remain compliant with GMP Assists in ensuring quality improvement The programme should cover all aspects of production and quality control be designed to detect shortcomings in the implementation of GMP recommend corrective actions set a timetable for corrective action to be completed PRINCIPLE OF SELF-INSPECTION 6

CONT….:

Performed routinely Also on special occasions such as Recalls Repeated rejections When a GMP inspection is announced by the national drug regulatory authority CONT…. 7

CONT…:

Self-inspection team should consist of personnel who: can evaluate the situation objectively have no conflict of interest, have no revenge in mind should have experience as observers of a self-inspection team before becoming a team member can be lead self-inspector with experience as team member Procedure should be documented Effective follow-up programme CONT… 8

TYPES OF SELF-INSPECION:

1. Self-inspection - informal (daily) Immediate correction 2. Self-inspection - formal (quarterly) Improve systems 3. QC - Internal (half yearly) Confirm compliance TYPES OF SELF-INSPECION 9

SELF-INSPECTION TEAM:

Team appointed by management, with: sufficient experience may be from inside or outside the company experts in their own field familiar with GMP Members from the different areas of experience It is advisable to have them from: Quality assurance/quality control Production & engineering Production planning & inventory control General affairs SELF-INSPECTION TEAM 10

FREQUENCY OF SELF-INSPECTION:

Frequency of inspection may be decided on the basis of the requirement of the company. carried out in two ways: Partially: carried out on one product line or facilities or SOPs. Complete: carried out at least once a year. It is also carried out in following events: Product recall Repeated rejection Announcement of inspection by regulatory authorities. FREQUENCY OF SELF-INSPECTION 11

ITEMS FOR SELF-INSPECTION:

To provide a min. & uniform std. of self-inspection the WHO text of GMPs has prescribed items of self-inspection. Personnel Premises including personnel facilities Maintenance of building & equipment Storage of starting material & finished product Equipment Production & IPQC Quality control documentation ITEMS FOR SELF-INSPECTION 12

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CONT… Sanitation & hygiene Validation & revalidation programme Calibration of instruments & measurement systems Recall procedures Complaints management Labels control Results of previous self-inspection & corrective steps taken Self-inspection report & follow-up action 13

CARRYING OUT SELF-INSPECTION:

Report prepared at completion of inspection, including: results evaluation conclusions recommended corrective measures Follow-up action Effective follow-up programme Company management to evaluate both the report and corrective actions CARRYING OUT SELF-INSPECTION 14

QUALITY AUDIT:

A quality audit is an examination of all or part of quality system with specific aim of improving it Usually conducted by outside experts or team appointed by management Useful to supplement self-inspection programme with quality audits May be extended to suppliers and contractors QUALITY AUDIT 15

REVIEW OF DOCUMENTATION FROM REGULATORY AUTHORITY:

Company file Site Master File Manufacturing licence Registration dossiers Reports Adverse Drug Reaction reports (ADRs) Previous inspections Records Complaints and recalls Regulatory test results (surveillance) REVIEW OF DOCUMENTATION FROM REGULATORY AUTHORITY 16

CONT…:

Annual report Complaints file Self inspection/internal audit reports Send a questionnaire to the manufacturer asking to provide specific information about the company Layout of site and diagrams Manuals Standard Operating Procedures CONT… 17

CHECKLIST FOR SELF-INSPECTION ON EQUIPMENTS:

Is the equipment adequate for intended use? Is it constructed in such a way that lubricants coolants etc. cannot contaminate the drug product? Does the equipment permit cleaning & maintenance? Does the equipment show its status i.e clean, dirty, batch contents? Are SOPs available for cleaning, maintenance & sanitization of major equipments? CHECKLIST FOR SELF-INSPECTION ON EQUIPMENTS 18

CONT…:

Are SOPs readily available to operators? Are scales & balances used for weighing calibrated regularly & records maintened ? If automatic electronic or mechanical equipment is used are there - written programmes for calibration/inspection? - records of such programmes ? - checks to ensure that changes are made only by authorized person? CONT… 19

EQUIPMENT: DESIGN & CONSTRUCTION:

Its design should be such that it can be cleaned & maintained easily Should not allow substances like lubricants, coolants to come into contact with any in process materials. Parts of equipment which come into contact with any raw material, intermediate, bulk or finished product should be made of material which would not be reactive, additive or adsorptive. Equipments for processing inflammable materials should be equipped with explosion proof electrical parts. EQUIPMENT: DESIGN & CONSTRUCTION 20

CONT…:

Should have appropriate recording device. If possible check whether there is alarm to indicate malfunctioning of equipment. Equipment’s design should conform GMPs principle. Design qualification should be carried out when equipment is purchased. CONT… 21

EQUIPMENT: INSTALLATION & LOCATION:

Equipment must be located in such a place where contamination is minimized. There should be sufficient distance between 2 equipments to avoid congestion All open mechanical belts & pulleys should be covered with safety guards. Water & other utilities service lines should be installed & they should have color scheme & should be marked so that these are recognized easily. EQUIPMENT: INSTALLATION & LOCATION 22

CONT…:

All pipes, tanks & jackets which handle steam or coolants should be properly insulated. In case of newly purchased equipments IQ, OQ & PQ should be performed. The latest text of WHO GMP under this element also recommend that a current drawings of critical equipment & support system should be maintained. CONT… 23

EQUIPMENT: CLEANING & MAINTENANCE:

Equipment should be cleaned regardless of their size. Large equipments which are too heavy to move should be cleaned on location. Tags with words like “equipment cleaned”, “cleaned” or “ready for used” are also inspected. Recording equipment should be calibrated at scheduled intervals & records of it should be checked. EQUIPMENT: CLEANING & MAINTENANCE 24

CONT…:

Cleaning & sanitization procedures employed for cleaning of equipments should be validated. Equipments if defective are removed. But if they cannot be removed out of section then it should be clearly labelled as “defective”. There should be preventive maintenance(PM) schedule for every major production & QC equipments & there records are maintained. CONT… 25

CONT…:

A format for keeping PM records is given below: NAME OF COMPANY: ADDRESS OF COMPANY: NAME OF MACHINE: IDENTIFICATION NO. OF MACHINE: LOCATION: CONT… 26

PowerPoint Presentation:

DATE OF LAST PM DATE OF PM TIME MAINTE-NANCE WORK PERFOR-MED BY ATTENDED BY CHECKED BY FROM TO 27

DOCUMENTS REQUIRED DURING INSPECTION:

Machine/equipment manuals. Machine/equipment layout drawing, showing the position of the equipment in the rooms. Certificates of MOC of equipment. Equipments validation reports. SOP on numbering of equipment List of major equipments with their distinctive identification no. or code. Equipment log for activities like operation, cleaning & maintenance SOP for all major equipments, cleaning & maintenances. DOCUMENTS REQUIRED DURING INSPECTION 28

REFERENCES::

P.P SHARMA, “HOW TO PRACTICE GMP”, 6 TH EDITION, VANDANA PUBLICATION, PG NO.- 100-102 & 154-156. SCHEDULE-M, PART-1, RULE 11. 29 REFERENCES:

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THANK YOU 30

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