QUALITY MANAGEMENT SYSTEM REQUIREMENTS IN PHARMACEUTICAL QUALITY CONTROL

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

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.

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

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

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

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 ü Size ü Facilities-water , waste disposal etc. ü Equipment- analytical, safety etc.

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

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

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.

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

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

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

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 Ø Distribute document -electronic and/or hard copy -who needs the document

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

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

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

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

Documentation ü Follow the SOP on Good Documentation Practice at all time v Use permanent ink, write clearly, strike out mistakes or errors neatly with single line, make entry at the time each action is taken v 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 ü Record data to its completeness ü Always sign and date ü Never indulge in fraudulent practices ü

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

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

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

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

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

Self Audit Formal Based or informal assessment of own processes 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

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

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

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.

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.

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

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

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 satisfaction. provide customer