Possible content of a Standard Operating Procedure (SOP) for Self-inspection: Performance, responsibility, reporting No claim for completeness or accuracy. Tasks and key aspects are just examples and might be adapted as long as they comply with given regulations. Possible content of a Standard Operating Procedure (SOP) for Self-inspection: Performance, responsibility, reporting VALIDITY/TRAINING 3 OBJECTIVES 3 AREA OF APPLICATION 4 AREAS OF RESPONSIBILITY 4 DEFINITIONS 4 DESCRIPTION OF THE SYSTEM USED TO IMPLEMENT SELFINSPECTIONS 5 INSPECTION PROGRAMME 7 AUDIT TEAM 8 INSPECTION PLAN (AGENDA) 8 ASSESSMENT OF OBSERVATIONS 9 INSPECTION REPORT 10 CORRECTIVE/ PREVENTIVE ACTIONS - CAPA 10 ANNEX 1: CUSTOMER AUTHORIZATION AND SCHEDULING (EXAMPLE) 11 Possible content of a Standard Operating Procedure (SOP) for Self-inspection: Performance, responsibility, reporting VALIDITY/TRAINING Define when the SOP will be valid and who needs to be trained (incl. time frame). OBJECTIVES Describe your objectives and systems for performing GDP self-inspections (storage, transport, distribution). These may include but is not limited to: Assessment of the quality system Compliance with GDP requirements and standards Checking processes descriptions Checking training status Verification of the effectiveness of the existing GDP system Evaluation and constant improvement of the suitability and effectiveness of the quality management system Possible content of a Standard Operating Procedure (SOP) for Self-inspection: Performance, responsibility, reporting AREA OF APPLICATION Define all areas to which this SOP applies to (departments, sites, regions). Take into consideration also specific (local) work instructions. AREAS OF RESPONSIBILITY Define who is responsible for (examples): Planning self-inspections Conducting the self-inspection Supporting the self-inspection Writing the report Distributing and archiving the respective reports Tracking the actions/ measures DEFINITIONS Provide definitions of commonly used phrases and abbreviations, like for example Self-inspection Observation Deviation CAPA (Corrective action and preventive action) Possible content of a Standard Operating Procedure (SOP) for Self-inspection: Performance, responsibility, reporting DESCRIPTION OF THE SYSTEM USED TO IMPLEMENT SELFINSPECTIONS Describe for example: 1. Areas of application (who will be inspected by self-inspections at regular intervals?) These may include but is not limited to: Receiving Area (Inbound) Warehouse (incl. packaging materials storage, raw materials storage, pharmaceuticals storage, hazardous materials storage, storage for anaesthetics, products under quarantine/ returns) Picking and packing, dispatch (Outbound) Technical materials qualification/ calibration (e.g. qualification of the warehouse and the temperature monitoring system) IT infrastructure (e.g. validation of the warehouse management system) Quality Management systems incl. training Transport and transport services Depending on the structure of the company, more areas might need to be inspected. Possible content of a Standard Operating Procedure (SOP) for Self-inspection: Performance, responsibility, reporting 2. Inspection process (what topics could be audited?) These may include but is not limited to: Storage and transport processes Buildings, rooms, media and equipment Staff and training Procedures, documentation and reports Quality Management systems Validation and qualification plans and reports Hygiene rules CAPA (e.g. corrective measures from previous in-house/external audits) Processing recalls Handling complaints Qualification of suppliers and recipients Contracts Depending on the structure of the company, more topics might need to be considered. Possible content of a Standard Operating Procedure (SOP) for Self-inspection: Performance, responsibility, reporting INSPECTION PROGRAMME Define how you set up your inspection programme with minimum timeframes. Define how you will set the frequency. Example clause: An annual inspection programme that includes all of the areas mentioned must be issued. The frequency of the inspections must be based on the quality status and current compliance with the GDP rules (risk assessment). However each site must be inspected at least once every year. GDP-QA is responsible for creating the inspection programme. The Responsible Person approves it. The intervals and times must be coordinated with the units/areas to be inspected. You can also define special occasions, when an unscheduled self-inspection may be required, e.g.: Before inspection by the authorities Before important customer audits After the conversion or initial set-up of equipment For verification of the corrective measures resulting from self-inspections, inspections by the authorities and customer audits Describe extent of an unscheduled self-inspection. Describe what will happen, if a self-inspection is postponed or cancelled. Possible content of a Standard Operating Procedure (SOP) for Self-inspection: Performance, responsibility, reporting AUDIT TEAM Describe role and responsibilities of lead auditor, co-auditor and the (local) quality assurance. INSPECTION PLAN (AGENDA) Define how you set up your set inspection plan (agenda) for the self-inspection. An inspection plan could cover: Self-inspection number (from the inspection programme) Name of area/unit Inspection date Name of participants (auditors) Focus of the self-inspection Schedule List of the instructions/documents to be checked List of observations from previous audits Define distribution of the inspection plan. Possible content of a Standard Operating Procedure (SOP) for Self-inspection: Performance, responsibility, reporting ASSESSMENT OF OBSERVATIONS Define how you will rate your observations. Example clauses: Critical1 o Non-conformity with the GDP regulations or with the existing QM system or other legal rules that make the product useless and in the worst case, could impact the patients' health. o And/or missing key elements from the relevant GDP guidelines. o Observations rated 'major' that are repeatedly recorded (from previous audits). Major o Non-conformity with the GDP regulations or with the existing QM system or other legal rules that adversely influences the product quality but does not have an influence on patients' health. Requires immediate remedial measures. o Non-conformities rated ‘minor’ that are repeatedly recorded (e.g. from previous audits). Minor o Non-conformities that do not have an influence on the product quality or product approval but require remedial measures. 1 If a self-inspection is performed by one auditor only and he/she has recorded critical observations, an additional specialist (from Company X-Pharmaceuticals or external) can be requested to verify the assessment. During the concluding meeting, the auditor should point out this option. Possible content of a Standard Operating Procedure (SOP) for Self-inspection: Performance, responsibility, reporting Describe how a final assessment can be made, for example: Satisfactory (no proof of non-conformity with regard to the requirements or product quality). Unsatisfactory (proof of non-conformity that does not have a major influence on the requirements or product quality and can be corrected with remedial measures). Critical (proof of serious non-conformities that have a critical influence on the requirements or product quality). INSPECTION REPORT Describe how you document the inspection, the observations and the outcome in a report. A report could contain: A summary of the processes inspected Detailed description and assessment of the observations Concluding assessment of the areas inspected Definition of corrective and preventive measures (incl. specific schedule) Define who needs to sign the audit report, who will get copies and who will keep the original (for how long). CORRECTIVE/ PREVENTIVE ACTIONS - CAPA Define how you will deal with irregularities and/or deficiencies including responsibilities. Possible content of a Standard Operating Procedure (SOP) for Self-inspection: Performance, responsibility, reporting ANNEX 1: CUSTOMER AUTHORIZATION AND SCHEDULING (EXAMPLE) Self-Inspection for the Qualification of Customers GDP Section 5.3 2.2 Suggested Audit Questions Examples of Evidence Which authorities are relevant to your Evidence of WDA(H)s available and/or customer base? How do you check that your customers records of initial and ongoing checks on relevant authorisation websites eg CQC, are bonafide? GMC, MHRA How regularly do you recheck? Person being audited having knowledge Pick a customer that you know receives of customer base and bonafide pharma goods and use them as an requirements example. Evidence of checks for unusual Show me the customer qualification for repetition of orders, sudden customer X, Y and Z increases of orders, and unusually low Do you carry out any sales pattern prices monitoring? RP Job description with this responsibility included and the RP How do you ensure that our customers should be able to describe how they are approved ensure that this responsibility is fulfilled. Evidence of any checking carried out by the RP Notes on Preparing a schedule: Assessing processes risk to the business and/or assessing the criticality of the processes to be audited will help to ensure a useful audit schedule designed not only to fit the requirements of the guideline but to aid process improvement. Considering the business and quality objectives, process changes, previous audit non conformities, relevant complaints and deviations, criticality of the process to product quality/patient safety will help answer questions such as: How many times annually should this process be audited Who should be involved in the audits A table and scoring system such as the one below may help: 1 – High, 2- Med, 3 - Low Possible content of a Standard Operating Procedure (SOP) for Self-inspection: Performance, responsibility, reporting Process Reference SOP### SOP### SOP### Process Personnel: Competence, Awareness and Training Change Management Material Storage No. of relevant changes Previous Internal Audit findings Number of relevant complaints No. of relevant deviations Total Lowest = higher audit priority 2 1 1 1 2 8 2 1 1 1 3 1 9 1 2 2 2 2 1 10 Criticality of the process to quality Relevance to Objectives 1 SOP### Validation 1 1 1 2 3 2 10 SOP### Complaints 1 2 1 3 1 3 11 1 2 2 2 3 1 11 1 2 1 3 1 3 11 2 1 3 1 3 1 11 2 2 1 1 3 2 11 1 2 3 2 3 1 12 2 2 1 3 2 2 12 2 2 2 2 3 1 12 3 1 2 2 2 2 12 2 1 3 2 2 2 12 1 2 3 1 3 2 12 SOP### SOP### SOP### SOP### SOP### SOP### SOP### SOP### SOP### SOP### Suspected falsified products Transport Corrective and Preventative Action Returns Information Technology – back up systems Document and Record Management Housekeeping and pest control Customer feedback Management Responsibility and Review Control and Monitoring of measuring devices Possible content of a Standard Operating Procedure (SOP) for Self-inspection: Performance, responsibility, reporting Process Reference SOP### SOP### SOP### SOP### SOP### SOP### SOP### Process Customer Qualification Self Inspection and Internal Audit FSCA Procedures (recall) Purchasing and Supplier Management Product Picking, Packing & Despatch Work Environment Receiving Goods – Goods Inwards No. of relevant changes Previous Internal Audit findings Number of relevant complaints No. of relevant deviations Total Lowest = higher audit priority 2 2 3 3 2 13 2 1 3 3 1 3 13 3 2 3 2 2 2 14 1 2 3 3 2 3 14 1 2 2 3 3 3 14 2 2 3 3 3 2 15 2 3 3 3 2 3 16 Criticality of the process to quality Relevance to Objectives 1