1. QUALITY ASSURANCE MANAGER NAFDAC CENTRAL DRUG CONTROL LABORATORY YABA
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.