QUALITY-SYSTEM-REQUIREMENTS-IN-PHARMACEUTICAL-QUALITY-CONTROL-LABORATORIES_-Ifudu-Colette.-N.ppt

QUALITY-SYSTEM-REQUIREMENTS-IN-PHARMACEUTICAL-QUALITY-CONTROL-LABORATORIES

1. QUALITY MANAGEMENT SYSTEM
REQUIREMENTS IN
PHARMACEUTICAL QUALITY
CONTROL LABORATORIES
.
COLETTE IFUDU
QUALITY ASSURANCE MANAGER
NAFDAC CENTRAL DRUG CONTROL
LABORATORY YABA

2. Learning Objective
To understand the requirements of QMS in Quality
Control Laboratory and be able to implement same in a
GMP environment and meet the quality objectives of
the company.

3. OUTLINE
Definition of QMS
Quality Management System
Responsibility
Resources
Organization
Personnel
Accommodation
Documentation
Occurrence Management
Self Audit
Monitoring laboratory QMS
Effective implementation of QMS in the laboratory

4. Quality Management System
Is the organizational
structure,responsibilities,procedures ,processes, and
resources for implementing quality management.
Organizational structure
Responsibilities
Processes and Procedures
- Laboratory process flow
Resources

5. Responsibility
The management should ensure that all parts of
the quality management system are adequately
resourced with competent personnel, suitable
premises ,equipment and facilities.

6. Resources
Ensure necessary resources are available for running & maintenance
of the laboratory
Adequate number of trained personnel
Trained deputies for specialized scientific personnel
Appropriate infrastructure
Size
Facilities-water ,waste disposal etc.
Equipment- analytical, safety etc.

7. Resources
Energy supply
Robust material procurement system to avoid
stock out
Provide support services
others

8. Organization
Organizational structure showing the place of the laboratory in
the parent organization.
Each manufacturer should have a QC department, independent
from production and other departments
Responsibilities of key personnel of the parent organization, the
Quality Control Manager and supervisors, Analysts and support
staff .
Personnel Awareness of their duties and contribution to meeting
management system objectives
Appropriate communication processes by top management
regarding the effectiveness of management system

9. Personnel
Use competent staff including contracted employees
Supervise as necessary
Document qualifications and training
Maintain documented training programs-effectiveness of training
actions shall be evaluated
Job description for all personnel
Special authorization for sampling,test,issuing test
reports/certificates and giving opinions.

10. Competency of Personnel
What is Competency?
Knowledge
Skill
Personal Attributes
-Complete knowledge of the method and proper capability to
carry out the analytical test and achieve an accurate and
reliable results.
Scheduled assessment of personnel competency should be
conducted.

11. Accommodation
Suitable for chemical and microbiological analytical testings'.
Monitor, control and record environmental conditions
Control access to laboratories
Effective separation between incompatible activities-prevent
cross contaminations
Good housekeeping

12. Documentation
SOPs
Work instructions
Logs and records
Reports
Computerized lab Information Management System (LIMS)
Data Integrity
Document creation, revision and review, control &
distribution
Records collection, review ,storage and retention

13. Documentation -Document Control
-Is a system for ensuring only current documents are used and
easy review and updating of documents.
-Good documentation practice is the bedrock of QMS
Create Document
-unique identification
-Approved by authourized person
Distribute document
-electronic and/or hard copy
-who needs the document
-Maintain distribution list

14. Document Control
Document Review
-done by same function that approved
-when is due for revision
-When there is need for alteration/change
Staff notified of change and review
-training (where necessary)
Old documents retrieved and placed by new ones
Master list of documents updated to reflect changes

15. Document Control
Authourized editions are available at the location needed
(right document at the right place)
Invalid or obsolete documents removed
Obsolete retained documents are marked
Periodic review and revision of procedures

16. Documentation- Control of Records
Quality and Technical Records
Retrievable and traceable
Retention time of records
Storage, security
Protect and back-up records stored electronically

17. Technical Records
Original Observations-
Worksheet and/or logbooks,
Equipment logs
test reports
Chromatographs
Spectra
Print-outs and sheets
Certificate of Analysis/calibration certificate

18. Documentation
Follow the SOP on Good Documentation Practice at all time
Use permanent ink, write clearly, strike out mistakes or errors
neatly with single line, make entry at the time each action is taken
Do not use pencil,tipp-ex,shorten signatures or use signature that
is not referenced, tick entries or leave any required space blank.
Never discard original Data
Record data to its completeness
Always sign and date
Never indulge in fraudulent practices

19. Attributes of Good Document
Simple :Content should be clear

Orderly: Easy to follow and check
Clear and Legible: Clear photocopies and readable handwriting

Sufficient space for data entry: For interactive document

Up-to-date :Amendments approved, signed and dated

Free form Errors

20. “MUST HAVE” PROCEDURES
The laboratory should establish, implement and maintain authorized written SOPs
including,
Change control
Internal audit and Self Assessment
Handling complaints
 Corrective and preventive actions
Personnel training
Validation and Verification
Qualification and Calibration


21. “ MUST HAVE”PROCEDURES
Hygiene;
Purchase and receipt of materials
Handling of reference substances
and reference materials
 Storage of materials, labeling and quarantine
 Equipment qualification and calibration
monitoring of environmental and storage conditions
Disposal of waste

22. “MUST HAVE”PROCEDURES
Safety measures,
Preventive maintenance and verification of instruments and equipment;
Sampling,
Testing of samples with descriptions of the methods and equipment used,
Investigation of atypical and OOS results,
Validation of analytical procedures,
Cleaning of laboratory facilities, including bench tops, equipment, work
stations, clean rooms (aseptic suites) and glassware;
SOPs can never be too many.

23. Occurrence Management
Deviation control
Investigation of failures (OOS,OOT)
Complaints
Root Cause analysis
Immediate action
Corrective action
Preventive action

24. Self Audit
Formal or informal assessment of own processes
Based on risk assessment of processes/SOPs
Schedule priority based on risk level –
High,Medium,low.
More frequent than internal audit.
Generate report and forward to QA
Implement CAPA

25. Monitoring laboratory QMS
“It isn't what you find……
it’s what you do about what you find”
Phillip Crosby.
Continuous monitoring is the key element to success in the quality system
Key performance indicators to monitor effectiveness of processes
Periodic audits carried out to verify compliance to procedures, standards and other
requirements of the quality management system.
Identified gaps corrected in a timely manner
Audit reports generated .
Process improvement

26. Effective implementation of QMS in
the Laboratory-1
Ensure that;
Analysis is conducted in a way that is compliant to the
requirements of GLP.
Management and personnel responsibilities clearly defined
Analysis conducted in a timely manner
Measures employed to assure the quality of test results strictly
adhered to.

27. Effective implementation of QMS in the
Laboratory-2
Maintain a current /up to date collection of records used and
generated in the laboratory
Ensure product traceability from receipt to final disposal.
-sample log, labeling, accompanying documents
Appropriate safety procedures and measures Provide adequate
supervision of personnel.
 Provision of overall technical resources needed to ensure the
required quality of operations.
Ensure adequate information flow between personnel at all levels.

28. Effective implementation of QMS in
the Laboratory-3
Make staff aware of the relevance and importance of their
activities and how they contribute to the achievement of the
objectives of the management system
Trainings and Competency assessments are conducted at
scheduled intervals.
Deviations from procedure are investigated and documented
Appropriate corrective and preventive action
Change control system established implemented, monitored.

29. Effective implementation of QMS in the
Laboratory-4
Management review of the QMS
Assessment of quality objectives and KPIs
Changes in work volume, regulatory requirements, company and
government polices etc.
Personnel requirements
Out come of reviews become action plans for continuous
improvement of the QMS.

30. Group Exercise
An API Company has just employed a Quality Control
manager to implement QMS in her Quality Control
laboratory. What are the things to put in place to
implement and maintain QMS in the laboratory and
possible problems that will be encountered.

31. SUMMARY
Laboratory controls in GMP is very important as most pronouncements
on the quality ,safety and efficacy of all starting
materials ,intermediate and finished products are determined by the
Quality control laboratory .
Implementing the requirements of QMS in the laboratories will
definitely improve product quality ,reduce wastage and possibility of
recalls, build personnel capacity, improve company image and
finance as well as facilitating continuous improvement of the
company’s quality policy and objectives and provide customer
satisfaction.