Compliance programs corrective actions

The principles of GLP require an independent quality assurance (QA) program to ensure that the study is being conducted in compliance with GLP. The QA personnel cannot overlap with those of the study because of the potential conflict of interest, but they may be part-time staff if the size of the study does not warrant a full-time QA section. The responsibilities of the QA unit are to maintain copies of plans, standard operating procedures, and in particular the master schedule of the study, and to verily, in writing, that these conform to GLP. The QA unit is responsible for inspections and audits, which must be documented and the results made available to the study director and the principal investigator. The QA unit also signs off on the final report. Any problems discovered or corrective action that is recommended by the unit must be documented and followed up. 

The corrective action plan may be contained within a validation plan. The validation plan is a document that describes the company s overall philosophy, intentions, timetable, and approach to be followed for the corrective action compliance program. The approach to be taken may consist of writing procedures, performing verifications, and/or performing qualification activities. Refer to Chapter 19 for information on remediation project. 

Suppliers should conduct SCRs on all critical software modules in order to capture deviations from programming standards, identify logic errors, and ensure software modularity. Tailored software developed to satisfy user requirements not catered for within the standard product offering should be a particular focus of attention as the risk of software failure increases for new software developments. SCRs should be documented in order to record observations raised against the software and resultant corrective actions. Further, documented evidence of the implementation of corrective actions should be available for inspection. Where software modules present a major risk to GxP compliance or evidence of internal SCRs is limited, the pharmaceutical organization should consider additional independent reviews. Table 31.12 details the scope and content of programming standards. 

Principle. The purpose of self-inspection is to evaluate the manufacturer s compliance with GMP in all aspects of production and quality control. The self-inspection program should be designed to detect any shortcomings in the implementation of GMP and to recommend the necessary corrective actions. Self-inspections should be performed routinely, and may be, in addition, performed on special occasions, e.g., in the case of product recalls or repeated rejections, or when an inspection by the heath authorities is announced. The team responsible for seif-inspection should consist of personnel who can evaluate the implementation of GMP objectively all recommendations for corrective action should be implemented. The procedure for self-inspection should be documented, and there should be an effective follow-up programme. 

The purpose of self-inspection is to review regularly the status and adequacy of the manufacturer s compliance to GMP. Self-Inspection programs are designed to seek out any defects in the quality assurance system and to establish corrective actions. 

The corrective action system should be the repository for all follow up actions required in the compliance program. The source for corrective actions, which need to be tracked, might include the following ... 

When you have finished the self-audit, take a serious look at any items for which you marked No for compliance. Develop a corrective action plan to address those items. It might mean developing a new policy, revising a policy, training or retraining in a particular area, or revising your disciplinary action program. 

Periodic, scheduled facility safety inspections are essential in any operational area, especially where hazardous tasks are performed on a regular basis. Compliance with safety inspection requirements should not be difficult to accomplish since similar requirements should already exist in an established occupational safety program. The facility inspection encompasses all facets of daily operation and considers the human-machine interface a primary candidate area for potential mishaps. Frequent facility inspections are an excellent method of maintaining current awareness of facility conditions and how those conditions affect, or might affect, the safe operation of that facility. A system should be in place to ensure implementation of corrective actions and to track repetitive items. Results of inspections should be properly documented and accountability for discrepant items appropriately determined and assigned in order for the inspection process to be effective. If properly performed, the facility safety inspection is an excellent tool in the overall success of the system safety function. 

The QA/QC program for CDB and CDU should address, at a minimum, procedures involved in calibration, establishment of control limits, internal QC analyses and maintaining control, and corrective-action protocols. The participating laboratory should develop and maintain procedures to assure that analyses of compliance samples are within control limits, and that these procedures are documented thoroughly in a QA/QC plan. 

Corrective Action Teams (CATs) have been used widely in manufacturing environments during the last ten years. The composition of the CAT may vary from company to company. In the case of several semiconductor companies, its composition has evolved as their compliance programs have matured. A CAT may be composed of the following functional areas ... 

Management should conduct these work observations and document them on a form. The form should describe the employee s ability to perform the task correctly and what corrective action or retraining was needed. It is important that the management document these observations as a means of demonstrating to OSHA that they are monitoring the effectiveness of their safety program and ensuring anployee compliance to established safety requirements. This information should be iucluded with the personnel file or input into a computerized system. 

Safety knowledge reviews and work observations should be routinely performed by the supervisor to measure the effectiveness of the company s safety program, training, PPE, compliance etc. At a minimum, the work observation form should include the employee s name, job title, year/date, supervisor name, work task(subject observed), OK/deviation, comments, and corrective action. This documentation should be maintained in the employee personnel file or a computerized file designed for this purpose. This information will be helpful in evaluating the company s accident prevention plan and will be used during an OSHA audit to document the company s safety training requirements. 

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