Audit-Guide-Checklist-1.pdf
- 1. GM P AUDIT CHECKLIST Page 1 of 11 1.0 General Controls Question Number GM P Section Number if Applicable Question or Instruction Yes, No, or NA 1.0.1 Does the facility and its many departments (organizational units) operate in a state of control as defined by the GMP regulations? 1.1 Organizational & M anagement Responsibilities Question Number GM P Section Number if Applicable Question or Instruction Yes, No, or NA 1.1.1 Does this facility/business unit operate under a facility or corporate quality policy? 1.1.2 §211.22(a) Does a Quality Assurance unit (department) exist as a separate organizational entity? 1.1.3 §211.22(a) Does the Quality Assurance unit alone have both the authority and responsibility to approve or reject all components, drug product containers and closures, in-process materials, packaging materials, labeling and drug products? 1.1.4 §211.22 Does the QA department or unit routinely review production records to ensure that procedures were followed and properly documented? 1.1.5 §211.22(b) Are adequate laboratory space, equipment, and qualified personnel available for required testing? 1.1.6 If any portion of testing is performed by a contractor, has the Quality Assurance unit inspected the contractor's site and verified that the laboratory space, equipment, qualified personnel and procedures are adequate? 1.1.7 Date of last inspection: 1.1.8 §211.22(c) Are all QA procedures in writing? 1.1.9 §211.22(c) Are all QA responsibilities in writing? 1.1.10 Are all written QA procedures current and approved? (Review log of procedures) 1.1.11 Are the procedures followed? (Examine records to ensure consistent recordkeeping that adequately documents testing.) 1.1.12 §211.25 Are QA supervisory personnel qualified by way of training and experience? 1.1.13 §211.25 Are other QA personnel, e.g., chemists, analysts, laboratory technicians) qualified by way of training and experience?
- 2. GM P AUDIT CHECKLIST Page 2 of 11 1.2 Documentation Question Number GM P Section Number if Applicable Question or Instruction Yes, No, or NA 1.2.1 §211.22(a) Does the QA unit have a person or department specifically charged with the responsibility of designing, revising, and obtaining approval for production and testing procedures, forms, and records? 1.2.2 §211.22(d) Does a written SOP exist for each record or form identifying how the form is to be completed and who signs and countersigns,? 1.2.3 §211.165(a )(b)(c) Are the production batch record and release test results reviewed for accuracy and completeness before a batch/lot of finished product is released? 1.3 Employee Orientation, Quality Awareness, and Job Training Question Number GM P Section Number if Applicable Question or Instruction Yes, No, or NA 1.3.1 Does this facility/business unit operate under a facility or corporate quality policy? 1.3.2 Circle the types of orientation provided to each new employee: (1) Company brochure (2) Literature describing GMP regulations and stressing importance of following instructions. (3) On-the-job training for each function to be performed (before the employee is allowed to perform such tasks). (4) Other: (write in) 1.3.3 §211.25(a) Does each employee receive retraining on an SOP (procedures) if critical changes have been made in the procedure? 1.3.4 Indicate how on-going, periodic GMP training is accomplished: (write in) 1.3.5 §211.25 Is all training documented in writing that indicates the following: • date of training • type of training • signatures of both the employee and the trainer?
- 3. GM P AUDIT CHECKLIST Page 3 of 11 1.3.6 §211.25 Are training records readily retrievable? Do records indicate what training a specific employee has received, and which employees have been trained on a particular procedure, or have attended a particular training program? 1.3.7 Are GMP trainers qualified through experience and training? 1.3.8 §211.25(a) Are supervisory personnel instructed to prohibit any employee that may adversely affect the safety or quality of drug products* from coming into direct contact with any drug component or containers for finished product? *Any physical condition as determined by medical examination or supervisory observation. 1.3.9 §211.28(d) Are employees required to report to supervisory personnel any health or physical condition that may have an adverse effect on drug product safety and purity? 1.3.10 §211.25(a) Are temporary employees given the same orientation as permanent employees? 1.3.11 §211.34 Are consultants who are hired to advise on any aspect of manufacture, processing, packing or holding, or approval for release of drug products, asked to provide evidence of their education, training, and experience? 1.3.12 §211.34 Are written records maintained for consultants stating: • name • address • qualifications • date of service • type of service provided? 1.4 Plant Safety and Security Question Number GM P Section Number if Applicable Question or Instruction Yes, No, or NA 1.4.1 Does this facility have a facility or corporate safety program? 1.4.2 Are safety procedures written? 1.4.3 Are safety procedures current? 1.4.4 Do employees receive safety orientation before working in the plant area? 1.4.5 Is safety training documented in a readily retrievable manner that states the name of the employee, the type of training, the date of the training, and the name of the trainer and the signature of the trainer and the participant? 1.4.6 Does this facility have a formal, written security policy? 1.4.7 Is access to the facility restricted?
- 4. GM P AUDIT CHECKLIST Page 4 of 11 1.4.8 Describe how entry is monitored/restricted: 1.4.9 Is a security person available 24 hours per day? 1.5 Internal Quality/GM P Audit Program Question Number GM P Section Number if Applicable Question or Instruction Yes, No, or NA 1.5.1 Does this business unit/facility have a written quality policy? 1.5.2 Is a copy of this quality policy furnished to all employees? 1.5.3 If "yes" to above, when is it provided? 1.5.4 Is training provided in quality improvement? 1.5.5 Does a formal auditing function exist in the Quality Assurance department? 1.5.6 Does a written SOP specify the qualifications (education, training, and experience) of those who conduct audits? 1.5.7 Does a written SOP specify the scope and frequency of audits and how such audits are to be documented? 1.5.8 Does a written SOP specify the distribution of the audit report? 1.6 Quality Cost Program Question Number GM P Section Number if Applicable Question or Instruction Yes, No, or NA 1.6.1 Does this facility have a periodic and formal review of the cost of quality? 1.6.2 Does this facility have the ability, through personnel, software, and accounting records, to identify and capture quality costs? 1.6.3 Does this facility make a conscious effort to reduce quality costs?
- 5. GM P AUDIT CHECKLIST Page 5 of 11 2.0 Design Control Not directly related to 21 CFR Parts 210 and 211 3.0 Facility Control 3.1 Facility Design and Layout Question Number GM P Section Number if Applicable Question or Instruction Yes, No, or NA 3.1.1 §211.42(a) Are all parts of the facility constructed in a way that makes them suitable for the manufacture, testing, and holding of drug products? 3.1.2 §211.42(b) Is there sufficient space in the facility for the type of work and typical volume of production? 3.1.3 Does the layout and organization of the facility prevent contamination? 3.2 Environmental Control Program Question Number GM P Section Number if Applicable Question or Instruction Yes, No, or NA 3.2.1 The facility is NOT situated in a location that potentially subjects workers or product to particulate matter, fumes, or infestations? 3.2.2 Are grounds free of standing water? 3.2.3 §211.44 Is lighting adequate in all areas? 3.2.4 §211.46 Is adequate ventilation provided? 3.2.5 §211.46 Is control of air pressure, dust, humidity, and temperature adequate for the manufacture, processing, storage or testing of drug products? 3.2.6 §211.46 If air filters are used, is there a written procedure specifying the frequency of inspection and replacement? 3.2.7 Are drains and routine cleaning procedures sufficient to prevent standing water inside the facility? 3.2.8 §211.42(d) Does the facility have separate air handling systems, if required, to prevent contamination? NOTE: THIS IS MANDATORY IF PENICILLIN IS PRESENT!
- 6. GM P AUDIT CHECKLIST Page 6 of 11 3.3 Facility M aintenance and Good Housekeeping Program Question Number GM P Section Number if Applicable Question or Instruction Yes, No, or NA 3.3.1 §211.56(a) Is this facility free from infestation by rodents, birds, insects and vermin? 3.3.2 §211.56(c) Does this facility have written procedures for the safe use of suitable, (i.e., those that are properly registered) rodenticides, insecticides, fungicides, and fumigating agents? 3.3.3 Is this facility maintained in a clean and sanitary condition? 3.3.4 Does this facility have written procedures that describe in sufficient detail the cleaning schedule, methods, equipment and material? 3.3.5 Does this facility have written procedures for the safe and correct use of cleaning and sanitizing agents? 3.3.6 §211.58 Are all parts of the facility maintained in a good state of repair? 3.3.7 §211.52 Is sewage, trash and other refuse disposed of in a safe and sanitary manner (and with sufficient frequency?) 3.4 Outside Contractor Control Program Question Number GM P Section Number if Applicable Question or Instruction Yes, No, or NA 3.4.1 §211.56(d) Are all parts of the facility constructed in a way that makes them suitable for the manufacture, testing, and holding of drug products? 3.4.2 Are contractors qualified by experience or training to perform tasks that may influence the production, packaging, or holding of drug products? 4.0 Equipment Control 4.1 Equipment Design and Placement Question Number GM P Section Number if Applicable Question or Instruction Yes, No, or NA 4.1.1 §211.63 Is all equipment used to manufacture, process or hold a drug product the appropriate design and size for its intended use?
- 7. GM P AUDIT CHECKLIST Page 7 of 11 4.1.2 Are the following pieces of equipment suitable for their purpose? Blender(s), Conveyor(s), Tablet, Presses, Capsule Fillers, Bottle Fillers, Other (specify). 4.1.3 Are the following pieces of equipment suitable in their size/capacity? Blender(s), Conveyor(s), Tablet, Presses, Capsule Fillers, Bottle Fillers, Other (specify). 4.1.4 Are the following pieces of equipment suitable in their design? Blender(s), Conveyor(s), Tablet, Presses, Capsule Fillers, Bottle Fillers, Other (specify). 4.1.5 Are the locations in the facility of the following pieces of equipment acceptable? Blender(s), Conveyor(s), Tablet, Presses, Capsule Fillers, Bottle Fillers, Other (specify). 4.1.6 Are the following pieces of equipment properly installed? Blender(s), Conveyor(s), Tablet, Presses, Capsule Fillers, Bottle Fillers, Other (specify). 4.1.7 Is there adequate space for the following pieces of equipment? Blender(s), Conveyor(s), Tablet, Presses, Capsule Fillers, Bottle Fillers, Other (specify). 4.1.8 §211.65(a) Are machine surfaces that contact materials or finished goods non-reactive, non-absorptive, and non- additive so as not to affect the product? 4.1.9 §211.65(b) Are design and operating precautions taken to ensure that lubricants or coolants or other operating substances do NOT come into contact with drug components or finished product? 4.1.10 §211.72 Fiber-releasing filters are NOT used in the production of injectable products? 4.1.11 §211.72 Asbestos filters are NOT used in the production of products? 4.1.12 Is each idle piece of equipment clearly marked "needs cleaning" or "cleaned; ready for service"? 4.1.13 Is equipment cleaned promptly after use? 4.1.14 Is idle equipment stored in a designated area? 4.1.15 §211.67(a)(b) Are written procedures available for each piece of equipment used in the manufacturing, processing or holding of components, in-process material, or finished product? 4.1.16 Do cleaning instructions include disassembly and drainage procedure, if required, to ensure that no cleaning solution or rinse remains in the equipment? 4.1.17 Does the cleaning procedure or startup procedure ensure that the equipment is systematically and thoroughly cleaned? 4.2 Equipment Identification Question Number GM P Section Number if Applicable Question or Instruction Yes, No, or NA 4.2.1 §211.105 Are all pieces of equipment clearly identified with easily visible markings? 4.2.2 §211.105(b) Are all pieces of equipment also marked with an identification number that corresponds with an entry in an equipment log?
- 8. GM P AUDIT CHECKLIST Page 8 of 11 4.2.3 Does each piece of equipment have written instructions for maintenance that includes a schedule for maintenance? 4.2.4 Is the maintenance log for each piece of equipment kept on or near the equipment? 4.3 Equipment M aintenance & Cleaning Question Number GM P Section Number if Applicable Question or Instruction Yes, No, or NA 4.3.1 §211.67(b) Are written procedures established for the cleaning and maintenance of equipment and utensils? 4.3.2 Are these procedures followed? 4.3.3 §211.67(b)( 1) Does a written procedure assign responsibility for the cleaning and maintenance of equipment? 4.3.4 §211.67(b)( 2) Has a written schedule been established and is it followed for the maintenance and cleaning of equipment? 4.3.5 Has the cleaning procedure been properly validated? 4.3.6 §211.67(b)( 2) If appropriate, is the equipment sanitized using a procedure written for this task? 4.3.7 §211.67(b)( 3) Has a sufficiently detailed cleaning and maintenance procedure been written for each different piece of equipment to identify any necessary disassembly and reassembly required to provide cleaning and maintenance? 4.3.8 §211.67(b)( 3) Does the procedure specify the removal or obliteration of production batch information from each piece of equipment during its cleaning? 4.3.9 Is equipment cleaned promptly after use? 4.3.10 Is clean equipment clearly identified as "clean" with a cleaning date shown on the equipment? 4.3.11 §211.67(b)( 5) Is clean equipment adequately protected against contamination prior to use? 4.3.12 §211.67(b) Is equipment inspected immediately prior to use? 4.3.13 §211.67(c) Are written records maintained on equipment cleaning, sanitizing and maintenance on or near each piece of equipment?
- 9. GM P AUDIT CHECKLIST Page 9 of 11 4.4 M easurement Equipment Calibration Program Question Number GM P Section Number if Applicable Question or Instruction Yes, No, or NA 4.4.1 §211.68(a) Does the facility have approved written procedures for checking and calibration of each piece of measurement equipment? (Verify procedure and log for each piece of equipment and note exceptions.) 4.4.2 §211.68(a) Are records of calibration checks and inspections maintained in a readily retrievable manner? 4.5 M easurement Equipment Calibration Program Question Number GM P Section Number if Applicable Question or Instruction Yes, No, or NA 4.5.1 §211.63 Verify that all pieces of equipment used in production, packaging, and quality assurance are capable of producing valid results. 4.5.2 §211.68(a) When computers are used to automate production or quality testing, have the computer and software been validated? 4.5.3 Have on-site tests of successive production runs or tests been used to qualify equipment? 4.5.4 Were tests repeated a sufficient number of times to ensure reliable results? 4.5.5 §211.63 Is each piece of equipment identified to its minimum and maximum capacities and minimum and maximum operating speeds for valid results? 4.5.6 Have performance characteristics been identified for each piece of equipment? (May be provided by the manufacturer, but must be verified under typical operations conditions.) 4.5.7 Have operating limits and tolerances for performance been established from performance characteristics?
- 10. GM P AUDIT CHECKLIST Page 10 of 11 5.0 M aterial/Component Control 5.1 M aterial/Component Specification and Purchasing Control Note: Although purchasing is not specifically addressed in the current GM P regulation, it is incumbent upon the user of components and materials to ensure quality of product, material or component. Question Number GM P Section Number if Applicable Question or Instruction Yes, No, or NA 5.1.1 Has each supplier/vendor of material or component been inspected/audited for proper manufacturing controls? (Review suppliers and audits and enter names, material supplied, and date last audited.) 5.2 M aterial/Component Receipt, Inspection, Sampling, and Laboratory Testing Question Number GM P Section Number if Applicable Question or Instruction Yes, No, or NA 5.2.1 §211.80(a) Does the facility have current written procedures for acceptance/rejections of drug products, containers, closures, labeling and packaging materials? (List selected materials and components in notebook and verify procedures.) 5.2.2 §211.80(d) Is each lot within each shipment of material or components assigned a distinctive code so material or component can be traced through manufacturing and distribution? 5.2.3 §211.82(a) Does inspection start with visual examination of each shipping container for appropriate labeling, signs of damage, or contamination? 5.2.4 §211.82(b) Is the number of representative samples taken from a container or lot based on statistical criteria and experience with each type of material or component? 5.2.5 §211.160(b) Is the sampling technique written and followed for each type of sample collected? 5.2.6 Is the quantity of sample collected sufficient for analysis and reserve in case retesting or verification is required? 5.2.7 §211.84(c)(2 ) *Containers are cleaned before samples are removed. 5.2.8 §211.84(c)(4 ) *Stratified samples are not composited for analysis. 5.2.9 §211.84(c)(5 *Containers from which samples have been taken are so marked indicating date and approximate
- 11. GM P AUDIT CHECKLIST Page 11 of 11 ) amount taken. 5.2.10 *Each sample container is clearly identified by material or component name, lot number, date sample taken, name of person taking sample, and original container identification. 5.2.11 §211.84(d)( 1)(2) *At least one test is conducted to confirm the identity of a raw material (bulk chemical or pharmaceutical) when a Certificate of Analysis is provided by supplier and accepted by QA. 5.2.12 *If a Certificate of Analysis is not accepted for a lot of material, then additional testing is conducted by a written protocol to determine suitability for purpose. 5.2.13 §211.84(d)( 6) *Microbiological testing is conducted where appropriate. *Verify that these steps are included in written procedures unless more specific procedures are followed. 5.3 M aterial Component Storage and Handling Verify that materials and components are stored and handled in a way that prevents contamination, mix-ups, and errors. Question Number GM P Section Number if Applicable Question or Instruction Yes, No, or NA 5.3.1 §211.42(b) Are incoming material and components quarantined until approved for use? 5.3.2 Are all materials handled in such a way to prevent contamination? 5.3.3 Are all materials stored off the floor? 5.3.4 Are materials spaced to allow for cleaning and inspection? 5.3.5 §211.122(d) Are labels for different products, strengths, dosage forms, etc., stored separately with suitable identification? 5.3.6 Is label storage area limited to authorized personnel? 5.3.7 §211.89 Are rejected components, material, and containers quarantined and clearly marked to prevent their use?