SOP Title: Internal Audit/Self Inspection
- Objective:
The self inspection procedure defines to determine the effectiveness of the Quality System, adherence to GMP requirements and verify compliance with the adopted Quality System. To detect the non-compliance and to recommend the necessary Corrective Actions for the improvement in the implementation of GMP.
- Scope:
This procedure is applicable to all operations, procedure, system, material, equipment, facility and utility at the site related to product manufacturing, testing and storage. Self Inspection shall be conducted in Production, QC, Warehouse, Engineering and QA Department to evaluate compliance of GMP norms.
- Responsibility:
All Departments: To cooperate in self inspection and implement the corrective actions of non compliances observed during inspection.
QA Departments: To ensure that non compliance report is communicated to all respective departments, corrective actions are taken and self inspection records are maintained.
- Accountability:
Head QA/Plant Head.
- Procedure:
5.1 Definitions:
Self Inspection: The self-inspection is the inspection carried out by the facility itself to evaluate the manufacturer’s compliance with GMP in all aspects of Production and Quality Control. The self inspection programme is designed to detect any shortcomings in the implementation of GMP and to recommend the necessary corrective actions.
5.2 Procedure:
| 5.2.1 | Composition of Self Inspection Team | |
| 5.2.1.1 | Self inspection team shall comprise of personnel having adequate qualifications, experience, training and familiar with GMP in the areas of Production, Warehouse, QC, QA and Engineering. | |
| 5.2.1.2 | Self inspection team shall be selected by management or QA Head who shall specifically conduct self inspection in the relevant areas at the site. | |
| 5.2.2 | Conduct of Self Inspection | |
| 5.2.2.1 | Self inspection shall be conducted as per the schedule by the self inspection team in all departments or area of interest viz. Production, QC, Warehouse, Engineering, QA etc in normal operation condition of the facility. | |
| 5.2.2.2 | Self inspection team shall prepare inspection schedule and send to QA Head which shall be then communicated to all departments. | |
| 5.2.2.3 | If any change in the schedule is needed, it shall be discussed with the Department Heads/Plant Head and then sent to the self inspection team. | |
| 5.2.2.4 | Self inspection team shall inspect the facility considering all aspects given in 5.2.4 inspection program. | |
| 5.2.2.5 | A checklist (Annexure) having specific contents i.e. points to be inspected, observation, corrective action to be taken, responsibility, target date, and compliance shall be followed for self inspection. | |
| 5.2.2.6 | Observations shall be filled in checklist online or concurrently during inspection for respective check points. | |
| 5.2.2.7 | Corrective actions for non compliances shall be discussed and recommended in the checklist with responsibility and set target date of implementation. | |
| 5.2.2.8 | If required, corrective actions shall be accomplished through separate CAPA process within set target date. | |
| 5.2.3 | Reporting | |
| 5.2.3.1 | All the observations made during the audit shall be recorded, reviewed as specified in Annexure and then sent to the QA Head and Management. | |
| 5.2.3.2 | The observation report and corrective action shall be discussed with the Concerned Department and compliance report shall be submitted to the self inspection team within 15 days. | |
| 5.2.3.3 | If required, self inspection team shall re-inspect the non compliance/ discrepancy to ensure compliance as per recommended corrective actions. | |
| 5.2.3.4 | Final self inspection report shall be prepared, reviewed and sent to the QA Head and Management. | |
| 5.2.3.5 | The outcome of the self inspection shall be taken up and discussed in the Management Review Meeting. | |
| 5.2.4 | Inspection Programme | |
| Written instructions for the self inspection shall have to include below mentioned aspects on the GMP requirements: | ||
| 5.2.4.1 | QMS. | |
| 5.2.4.2 | Personnel. | |
| 5.2.4.3 | Maintenance of buildings & equipment. | |
| 5.2.4.4 | Equipment. | |
| 5.2.4.5 | Premises including personnel facilities. | |
| 5.2.4.6 | Storage of Starting Materials & Finished Product. | |
| 5.2.4.7 | Production & In process Controls. | |
| 5.2.4.8 | Quality Control System. | |
| 5.2.4.9 | Documentation. | |
| 5.2.4.10 | Sanitization & Hygiène. | |
| 5.2.4.11 | Validation & Revalidation Programmes. | |
| 5.2.4.12 | Calibration of Instruments or measurement systems. | |
| 5.2.4.13 | Recall procedures. | |
| 5.2.4.14 | Complaint management. | |
| 5.2.4.15 | Labels Control. | |
| 5.2.4.16 | Results of previous self inspection and any corrective steps taken. | |
| 5.2.5 | Quality Management System (QMS) | |
| 5.2.5.1 | Suitability and effectiveness of Quality Systems and its control, responsibility and awareness of the Quality System. The company Quality Policy, objective and its practical use, quality audits and record for any desired improvement. | |
| 5.2.6 | Personnel | |
| 5.2.6.1 | Organization chart including key personnel. |
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| 5.2.6.2 | Adequate number of personnel in each department. | |
| 5.2.6.3 | Required qualification and experience to perform their work satisfactorily. | |
| 5.2.6.4 | Job responsibilities of key personnel and authorized person for finished product release. | |
| 5.2.6.5 | Medical Examination for safe working. | |
| 5.2.6.6 | Training of all personnel in the practices of clothing & personal hygiene and written instruction related to personal hygiene. | |
| 5.2.6.7 | Instructions to prohibit cosmetic items, eating, drinking, chewing, smoking or storage of foods in Production areas. | |
| 5.2.7 | Building and Premises | |
| 5.2.7.1 | Design, location, and construction for suitability of carried out operation and to minimize the risk of errors and effective cleaning and maintenance in order to avoid cross contamination. |
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| 5.2.7.2 | Electrical supply, lighting, Temperature, Humidity and Ventilation that can adversely affect the pharmaceutical products during manufacturing and storage or the accurate functioning of equipment. | |
| 5.2.7.3 | Provisions made to prevent entry of insects and rodents. | |
| 5.2.7.4 | Provisions made to restrict entry of unauthorized personnel in Production, Quality Control and Storage areas. | |
| 5.2.8 | Ancillary Areas |
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| 5.2.8.1 | Suitability of rest & refreshment sufficient number for workers, separation from other areas, maintained at clean and sanitary condition with washing facilities. | |
| 5.2.8.2 | The maintenance workshop separated from Production and QC area. | |
| 5.2.9 | Storage Areas | |
| 5.2.9.1 | Capacity to allow orderly storage of the various categories of materials. |
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| 5.2.9.2 | Suitability, separation of sampling area, weighing area, Quarantine area, Raw, Packing, Intermediate Bulk and Finished Materials, storage of Rejected, Recalled or Returned materials or products. | |
| 5.2.9.3 | Walls and ceilings cracks, crevices and repair. | |
| 5.2.9.4 | Special storage conditions of Temperature and Relative Humidity. | |
| 5.2.9.5 | Secure and separate storage area for sensitizing materials. | |
| 5.2.9.6 | Criteria of controlled drugs to meet with regulations of storage room. | |
| 5.2.9.7 | Receiving bays and physical (or by other means) separation of different categories of rooms. | |
| 5.2.10 | Weighing Areas | |
| 5.2.10.1 | Sufficient space for weighing of Starting Materials for the provision of dust control in the weighing area. | |
| 5.2.11 | Production Areas | |
| 5.2.11.1 | Dedicated and self contained facilities provided for producing sensitizing materials. |
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| 5.2.11.2 | Separate area for non-medicinal products. | |
| 5.2.11.3 | Production carried out in logical order, uniflow system and required cleanliness levels. | |
| 5.2.11.4 | Adequate space for working, in-process and storage and logical positioning of equipment and materials. | |
| 5.2.11.5 | Smoothness of wall, floors and ceiling and free from cracks and open joints. | |
| 5.2.11.6 | Accessibility to pipe work, light fittings, HVAC and other services from outside the manufacturing areas. | |
| 5.2.11.7 | Drains for trapped gullies or \shallow design to facilitate cleaning and disinfection. | |
| 5.2.11.8 | Dispensing area and its operation. | |
| 5.2.11.9 | Segregation of packaging lines and well lit area. | |
| 5.2.11.10 | Change room space and changing facilities. | |
| 5.2.11.11 | Sealing of doors for no loss of air, controlled and maintained Temperature Relative Humidity, number of air changes of circulating air in the section, microbial count of the section, disinfection and its effectiveness in the section requisite level of cleanliness. | |
| 5.2.12 | Quality Control Area | |
| 5.2.12.1 | Design of laboratories to suit the operations carried out, suitability of construction materials, and prevention of fumes. |
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| 5.2.12.2 | Ventilation, working of air handling units, storage space for samples, reference standards & working standards. | |
| 5.2.12.3 | Separate room for sensitive instruments with Temperature and Humidity control. | |
| 5.2.12.4 | Separate laboratory for microbiological tests. | |
| 5.2.12.5 | Air quality of the section, microbial count of the microbiological section, disinfection and its effectiveness in the section. | |
| 5.2.12.6 | Requisite level of cleanliness, space of working, orderly and logical positioning of equipments and material. | |
| 5.2.12.7 | Walls, floors and ceilings for cracks and repairs. | |
| 5.2.13 | Equipment | |
| 5.2.13.1 | Equipment location, design and construction to suit the operation carried out. |
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| 5.2.13.2 | The layout and design of the equipments for the purpose of effective cleaning & maintenance. | |
| 5.2.13.3 | Labeling of pipe lines of equipments to indicate the contents and directions of flow. | |
| 5.2.13.4 | Equipments shall be checked for serving its intended use, calibration & validation on scheduled basis. | |
| 5.2.13.5 | Procedure for handling defective equipments in the area. | |
| 5.2.13.6 | Washing and cleaning equipments system of equipment to ensure no risk of contamination. | |
| 5.2.13.7 | Sanitization and microbial contamination control of purified water generation and distribution system. | |
| 5.2.14 | Production and inprocess control | |
| 5.2.14.1 | All incoming materials and Finished Products for proper “Quarantine” immediately after receipt or processing till the release. |
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| 5.2.14.2 | All materials and Finished Products for proper storage and in orderly fashion to permit batch segregation and stock rotation by a FIFO rule. | |
| 5.2.14.3 | Starting materials supplies for Suppliers Name/Manufacturer Name which comply approved vendors list. | |
| 5.2.14.4 | Vendor evaluation and approval procedure and records. | |
| 5.2.14.5 | Containers of starting materials for integrity of packaging and seal. | |
| 5.2.14.6 | Procedure for handling of defective or damage container receipt. | |
| 5.2.14.7 | The designated Name of the product and the Reference Code. | |
| 5.2.14.8 | The Batch No. given by the supplier or manufacturer. | |
| 5.2.14.9 | The appropriate, status of the contents (e.g. Under Quarantine, Under Test, Released or Rejected). | |
| 5.2.14.10 | The appropriate Expiry Date or a date beyond which re-testing is necessary. | |
| 5.2.14.11 | Testing and release procedure of starting materials. | |
| 5.2.14.12 | Dispensing procedure and area. | |
| 5.2.14.13 | Intermediate & Bulk Products for appropriate storage conditions, in-process critical parameters controlled procedure.
Identification of inprocess materials. Any deviations from the procedure and deviation Records. |
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| 5.2.15 | Quality Control | |
| 5.2.15.1 | Approved specifications & standard testing procedures, sampling procedures for Raw, Packing & in-process materials, procedure of releasing finished materials. |
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| 5.2.15.2 | Stability data of the products manufactured (accelerated as well as routine programmed analysis), standard procedure of investigating product related complaints and the procedure for the procuring of reference standards and their records of analysis for the purpose as reference standard are checked. | |
| 5.2.15.3 | Validity of prepared laboratory reagents and cultures. | |
| 5.2.16 | Documentation | |
| 5.2.16.1 | Master Formula Records for each products and batch size manufactured. |
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| 5.2.16.2 | Batch production records for each product and data recording. | |
| 5.2.16.3 | Production details, including reference to the main equipment used and batch yield, reference number (or Analytical Report No.) of starting materials used in production, the record of in-process controls being followed and results obtained. | |
| 5.2.16. | Details of any recoverable materials, initials of operators and the date of signature on Packaging Records, all Analytical Records related to batch processed the decision on the release or rejection of the batch, with date and signature of the person responsible for the decision. | |
| 5.2.16. | SOPs provided to all equipment for operation, cleaning, calibration and maintenance requirements. | |
| 5.2.16. | Documents compliance with marketing authorization. | |
| 5.2.16. | Control on document and data control and change-over procedures. | |
| 5.2.16. | Data entries shall be clear, legible and alteration made to the entry has been signed and dated. | |
| 5.2.16. | Data access restriction system for electronic data. | |
| 5.2.16. | Specifications for starting material Intermediate/Bulk Product, Finished Products, procedures for receipt and storage, sampling, testing, complaints and recall method. | |
| 5.2.17 | Sanitation & Hygiene | |
| 5.2.17.1 | Availability of written procedure for cleaning of the manufacturing area, checked for written sanitation programme. | |
| 5.2.17.2 | Written instruction for hygiene, when manufacturing and handling the goods and instruction related to health, hygiene practices and clothing or personnel, disposal procedure of waste materials. | |
| 5.2.18 | Validation Programme | |
| 5.2.18.1 | Availability of Validation Master Plan, written procedure of validation of equipments (protocol), instruments, cleaning, disinfecting agents and disinfection related to the production process. |
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| 5.2.18.2 | Reports and records generated related to validation (including URS, DQ, IQ, OQ and PQ) shall be checked. | |
| 5.2.19 | Calibration Programme | |
| 5.2.19.1 | Written procedure and record of calibration of balances, laboratory equipments, Pressure Gauges, Temperature recording devices, measuring equipments and hygrometers with status label. | |
| 5.2.20 | Recalled Products | |
| 5.15.1 | Recalled Products, including Quantity, Batch No., Type of Complaint, analysis of product and decision; secured area to keep recalled product till the decision. Reconciliation of delivered and recovered quantities. | |
| 5.15.2 | Record of returned products, analysis of product, decision of release or re-labeling or reprocessing or destroying. | |
| 5.2.21 | Complaints | |
| 5.2.21.1 | Written procedure for handling of complaints and responsible person to evaluate the complaint status. |
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| 5.2.21.2 | Action taken on complaints and recalls made. | |
| 5.2.21.3 | Complaint trend analysis and efforts to minimize complaints with maximum probability. | |
| 5.2.21.4 | History of complaints and response to complainant. | |
| 5.2.22 | Label Control | |
| 5.2.22.1 | Checked for proper storage and distribution of labels. Control over coded labels and destruction of the same to avoid misuse. | |
| 5.2.23 | Training | |
| 5.2.23.1 | Training to all personnel on basic GMP. | |
| 5.2.23.2 | All new personnel passed through Induction Training of GMP and relevant job related training. | |
| 5.2.23.3 | Training need identified with training manuals and media. | |
| 5.2.23.4 | Annual Training Plans, training schedules and training faculty made periodically. | |
| 5.2.23.5 | Personal record of persons trained with scope of training. | |
| 5.2.23.6 | Training Assessment Record of each individual. | |
| 5.2.23.7 | Specific training records on Health & Safety, First Aid and Fire fighting. | |
| 5.2.24 | Frequency | |
| 5.2.24.1 | Full self-inspection shall be undertaken at a frequency of not less than once in a six month and in case of product recall or repeated rejections. Additional inspections may be undertaken as required, where specific issues require. | |
- Abbreviation:
| Abbreviation | Expansion |
| GMP | Good Manufacturing Practice |
| QMS | Quality Management System |
| HVAC | Heating Ventilation and Air Condition |
| FIFO | First In First Out |
| SOP | Standard Operating Procedure |
| CAPA | Corrective And Preventive Action |
| URS | User Requirement Specification |
| DQ | Design Qualification |
| IQ | Installation Qualification |
| OQ | Operational Qualification |
| PQ | Performance Qualification |
*Note – Ready to use SOP available in “DOWNLOAD” Section.