Question Instructions/questions (note any exceptions and comments in notebook).

Yes, No, or NA

1.0

General Controls
Does the facility and its departments (organizational units) operate in a state of control as defined by the GMP regulations?

1.1
1.101

Organizational & Management Responsibilities

Does this facility/business unit operate under a facility or corporate quality policy?

1.102

211.22(a) Does a Quality Assurance unit (department) exist as a separate organizational entity? 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? 211.22 Does the QA department or unit routinely review production records to ensure that procedures were followed and properly documented? 211.22(b) Are adequate laboratory space, equipment, and qualified personnel available for required testing? If any portion of testing is performed by a contractor, has the Quality Assurance unit inspected the contractors site and verified that the laboratory space, equipment, qualified personnel and procedures are adequate? Date of last inspection:____________________ 211.22(c) Are all QA procedures in writing? 211.22(c) Are all QA responsibilities in writing? Are all written QA procedures current and approved? (Review log of procedures) Are the procedures followed? (Examine records to ensure consistent record-keeping that adequately documents testing.) 211.25 Are QA supervisory personnel qualified by way of training and experience? 211.25 Are other QA personnel, e.g., chemists, analysts, laboratory technicians) qualified by way of training and experience?

1.103

1.104

1.105

1.106

1.107 1.108 1.109 1.110 1.111

1.112

1.113

1.2

Document Control Program

211.22(a) Does the QA unit have a person or department specifically charged with the responsibility 1.201 of designing, revising, and obtaining approval for production and testing procedures, forms, and records?

1.202

211.22(d) Does a written SOP, which identifies how the form is to be completed and who signs and countersigns, exist for each record or form? 211.165(a)(b)(c) Is the production batch record and release test results reviewed for accuracy and completeness before a batch/lot of finished product is released?

1.203

1.3

Employee Orientation, Quality Awareness, and Job Training

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 1.301 training for each function to be performed (before the employee is allowed to perform such tasks). (4) Other: enter in notebook. 211.25(a) Does each employee receive retraining on an SOP (procedures) if critical changes have been made in the procedure?

1.302

1.303 Indicate how on-going, periodic GMP training is accomplished. 211.25 is all training documented in writing that indicates the date of the training, the type of training, and the signature of both the employee and the trainer?

1.304

211.25 Are training records readily retrievable in a manner that enables one to determine what 1.305 training an employee has received, which employees have been trained on a particular procedure, or have attended a particular training program? 1.306 Are GMP trainers qualified through experience and training? 211.25(a) Are supervisory personnel instructed to prohibit any employee who, because of any physical condition (as determined by medical examination or supervisory observation) that may 1.307 adversely affect the safety or quality of drug products, from coming into direct contact with any drug component or immediate containers for finished product?

1.308

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?

1.309 211.25(a) Are temporary employees given the same orientation as permanent employees? 211.34 Are consultants, who are hired to advise on any aspect of manufacture, processing, packing 1.310 or holding, of approval for release of drug products, asked to provide evidence of their education, training, and experience? 211.34 Are written records maintained stating the name, address, qualifications, and date of service for any consultants and the type of service they provide?

1.311

1.4

Plant Safety and Security

1.401 Does this facility have a facility or corporate safety program?

1.402 Are safety procedures written? 1.403 Are safety procedures current? 1.404 Do employees receive safety orientation before working in the plant area? Is safety training documented in a readily retrievable manner that states the name of the employee, 1.405 the type of training, the date of the training, and the name of the trainer and the signature of the trainer and the participant? 1.406 Does this facility have a formal, written security policy? 1.407 Is access to the facility restricted? 1.408 Describe how entry is monitored/restricted: 1.409 Is a security person available 24 hours per day?

1.5

Internal Quality/GMP Audit Program

1.501 Does this business unit/facility have a written quality policy? 1.502 Is a copy of this quality policy furnished to all employees? 1.503 If "yes" to above, when provided? __________________ 1.504 Is training provided in quality improvement? 1.505 Does a formal auditing function exist in the Quality Assurance department? 1.506 Does a written SOP specify who shall conduct audits and qualifications (education, training, and experience) for those who conduct audits? Does a written SOP specify the scope and frequency of audits and how such audits are to be documented?

1.507

1.508 Does a written SOP specify the distribution of the audit report?

1.6

Quality Cost Program

1.601 Does this facility have a periodic and formal review of the cost of quality? 1.602 Does this facility have the ability, through personnel, software, and accounting records, to identify and capture quality costs?

1.603 Does this facility make a conscious effort to reduce quality costs?

2.0

Design Control
Not directly related to the Drug Regulation

3.0 Facility Control

3.1 Facility Design and Layout

3.101

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? 211.42(b) Is there sufficient space in the facility for the type of work and typical volume of production?

3.102

3.103 Does the layout and organization of the facility prevent contamination?

3.2
3.201

Environmental Control Program

The facility is NOT situated in a location that potentially subjects workers or product to particulate matter, fumes, or infestations?

3.202 Are grounds free of standing water? 3.203 211.44 Is lighting adequate in all areas? 3.204 211.46 Is adequate ventilation provided? 3.205 211.46 Is control of air pressure, dust, humidity and temperature adequate for the manufacture, processing, storage or testing of drug products? 211.46 If air filters are used, is there a written procedure specifying the frequency of inspection and replacement?

3.206

3.207 Are drains and routine cleaning procedures sufficient to prevent standing water inside the facility? 211.42(d) Does the facility have separate air handling systems, if required, to prevent contamination? (MANDATORY IF PENICILLIN IS PRESENT!)

3.208

3.3

Facility Maintenance and Good Housekeeping Program

3.301 211.56(a) Is this facility free from infestation by rodents, birds, insects and vermin?

3.302

211.56(c) Does this facility have written procedures for the safe use of suitable, (e.g. those that are properly registered) rodenticides, insecticides, fungicides, and fumigating agents?

3.303 Is this facility maintained in a clean and sanitary condition? 3.304 Does this facility have written procedures that describe in sufficient detail the cleaning schedule, methods, equipment and material?

3.305 Does this facility have written procedures for the safe and correct use of cleaning and sanitizing agents? 3.306 211.58 Are all parts of the facility maintained in a good state of repair? 3.307 211.52 Is sewage, trash and other refuse disposed of in a safe and sanitary manner (and with sufficient frequency?)

3.4

Outside Contractor Control Program

3.401

211.56(d) Are contractors and temporary employees required to perform their work under sanitary conditions? Are contractors qualified by experience or training to perform tasks that may influence the production, packaging, or holding of drug products?

3.402

4.0
4.1
4.101

Equipment Control
Equipment Design and Placement
211.63 Is all equipment used to manufacture, process or hold a drug product of appropriate design and size for its intended use? Are the following pieces of equipment suitable for their purpose? Blender(s), Conveyor(s), Tablet, Presses, Capsule Fillers, Bottle Fillers, Other (specify). Are the following pieces of equipment suitable in their size/capacity? Blender(s), Conveyor(s), Tablet, Presses, Capsule Fillers, Bottle Fillers, Other (specify). Are the following pieces of equipment suitable in their design? Blender(s), Conveyor(s), Tablet, Presses, Capsule Fillers, Bottle Fillers, Other (specify). 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). Are the following pieces of equipment properly installed? Blender(s), Conveyor(s), Tablet, Presses, Capsule Fillers, Bottle Fillers, Other (specify). Is there adequate space for the following pieces of equipment? Blender(s), Conveyor(s), Tablet, Presses, Capsule Fillers, Bottle Fillers, Other (specify). 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? 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?

4.102

4.103

4.104

4.105

4.106

4.107

4.108

4.109

4.110 211.72 Fiber-releasing filters are NOT used in the production of injectable products? 4.111 211.72 Asbestos filters are NOT used in the production of products? 4.112 Is each idle piece of equipment clearly marked "needs cleaning" or "cleaned; ready for service"? 4.113 Is equipment cleaned promptly after use? 4.114 Is idle equipment stored in a designated area? 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?

4.115

4.116

Do cleaning instructions include disassembly and drainage procedure, if required, to ensure that no cleaning solution or rinse remains in the equipment? Does the cleaning procedure or startup procedure ensure that the equipment is systematically and thoroughly cleaned?

4.117

4.2

Equipment Identification

4.201 211.105 Are all pieces of equipment clearly identified with easily visible markings? 211.105(b) Are all pieces of equipment also marked with an identification number that corresponds with an entry in an equipment log? Does each piece of equipment have written instructions for maintenance that includes a schedule for maintenance?

4.202

4.203

4.204 Is the maintenance log for each piece of equipment kept on or near the equipment?

4.3
4.301

Equipment Maintenance & Cleaning

211.67(b) Are written procedures established for the cleaning and maintenance of equipment and utensils?

4.302 Are these procedures followed? 4.303 211.67(b)(1) Does a written procedure assign responsibility for the cleaning and maintenance of equipment? 211.67(b)(2) Has a written schedule been established and is it followed for the maintenance and cleaning of equipment?

4.304

4.305 Has the cleaning procedure been properly validated? 4.306 211.67(b)(2) If appropriate, is the equipment sanitized using a procedure written for this task? 211.67(b)(3) Has a sufficiently detailed cleaning and maintenance procedure been written for each 4.307 different piece of equipment to identify any necessary disassembly and reassembly required to provide cleaning and maintenance? 4.308 211.67(b)(3) Does the procedure specify the removal or obliteration of production batch information from each piece of equipment during its cleaning?

4.309 Is equipment cleaned promptly after use? 4.310 Is clean equipment clearly identified as "clean" with a cleaning date shown on the equipment? 4.311 211.67(b)(5) Is clean equipment adequately protected against contamination prior to use? 4.312 211.67(b) Is equipment inspected immediately prior to use? 4.313 211.67(c) Are written records maintained on equipment cleaning, sanitizing and maintenance on or near each piece of equipment?

4.4

Measurement Equipment Calibration Program

211.68(a) Does the facility have approved written procedures for checking and calibration of each 4.401 piece of measurement equipment? (Verify procedure and log for each piece of equipment and note exceptions in notebook with cross reference.) 4.402 211.68(a) Are records of calibration checks and inspections maintained in a readily retrievable manner?

4.5
4.501 4.502

Equipment Qualification Program

211.63 Verify that all pieces of equipment used in production, packaging, and quality assurance are capable of producing valid results. 211.68(a) When computers are used to automate production or quality testing, have the computer and software been validated?

4.503 Have on-site tests of successive production runs or tests been used to qualify equipment? 4.504 Were tests repeated a sufficient number of times to ensure reliable results? 4.505 4.506 4.507 211.63 Is each piece of equipment identified to its minimum and maximum capacities and minimum and maximum operating speeds for valid results? Have performance characteristics been identified for each piece of equipment? (May be provided by the manufacturer, but must be verified under typical operations conditions.) Have operating limits and tolerances for performance been established from performance characteristics?

5.0 Material/Component Control

5.1 Material/Component Specification and Purchasing Control
Although purchasing is not specifically addressed in the current GMP regulation, incumbent upon user of components and materials to ensure quality of product, material or component. Has each supplier/vendor of material or component been inspected/audited for proper manufacturing 5.101 controls? (Review suppliers and audits and enter names, material supplied, and date last audited in notebook.)

5.2

Material/Component Receipt, Inspection, Sampling, and Laboratory Testing

211.80(a) Does the facility have current written procedures for acceptance/rejections of drug 5.201 products, containers, closures, labeling and packaging materials? (List selected materials and components in notebook and verify procedures.) 5.202 5.203 5.204 211.80(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? 211.82(a) Does inspection start with visual examination of each shipping container for appropriate labeling, signs of damage, or contamination? 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?

5.205 211.160(b) Is the sampling technique written and followed for each type of sample collected? 5.206 Is the quantity of sample collected sufficient for analysis and reserve in case retesting or verification is required? Verify that the following steps are included in written procedures unless more specific procedures are followed: 5.207 211.84(c)(2) Containers are cleaned before samples are removed. 5.208 211.84(c)(4) Stratified samples are not composited for analysis.

5.209 5.210

211.84(c)(5) Containers from which samples have been taken are so marked indicating date and approximate amount taken. 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.

211.84(d)(1)(2) At least one test is conducted to confirm the identity of a raw material (bulk 5.211 chemical or pharmaceutical) when a Certificate of Analysis is provided by supplier and accepted by QA. 5.212 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.

5.213 211.84(d)(6) Microbiological testing is conducted where appropriate.

5.3

Material Component Storage and Handling

(Verify that materials and components are stored and handled in a way that prevents contamination, mixups, and errors.)

5.301 211.42(b) Are incoming material and components quarantined until approved for use? 5.302 Are all materials handled in such a way to prevent contamination? 5.303 Are all materials stored off the floor? 5.304 Are materials spaced to allow for cleaning and inspection? 5.305 211.122(d) Are labels for different products, strengths, dosage forms, etc., stored separately with suitable identification?

5.306 Is label storage area limited to authorized personnel? 5.307 211.89 Are rejected components, material, and containers quarantined and clearly marked to prevent their use?

5.4

Inventory Control Program

Does the program identify destruction dates for obsolete or out-dated materials, components, and packaging materials?

5.401 211.142 Are inventory control procedures written? 5.402

5.403 211.150(a) Is stock rotated to ensure that the oldest approved product or material is used first? 5.404 211.184(e) Is destruction of materials documented in a way that clearly identifies the material destroyed and the date on which destruction took place?

5.5

Vendor (Supplier) Control Program

5.501 Are vendors periodically inspected according to a written procedure? 5.502 Is the procedure for confirming vendor test results written and followed?

6.0 Operational Control

6.1
6.101

Material/Component/Label Verification, Storage, and Handling

211.87 Do written procedures identify storage time beyond which components, containers, and closures must be reexamined before use?

6.102 211.87 Is release of retested material clearly identified for use? 6.103 Are retesting information supplements originally obtained? 6.104 Do written procedures identify steps in the dispensing of material for production?

6.105 6.106 6.107 6.108

Do these procedures include (1) release by QC, (2)Documentation of correct weight or measure, and (3) Proper identification of containers? Does a second person observe weighing/measuring/dispensing and verify accuracy with a second signature? 211.101(c) Is the addition of each component documented by the person adding the material during manufacturing? 211.101(d) Does a second person observe each addition of material and document verification with a second signature?

6.109 211.125(a) Does a written procedure specify who is authorized to issue labels? 6.110 6.111 211.125(a) Does a written procedure specify how labels are issued, used, reconciled with production, returned when unused, and the specific steps for evaluation of any discrepancies? 211.125(d) Do written procedures call for destruction of excess labeling on which lot or control numbers have been stamped or imprinted?

6.2
6.201 6.202

Equipment/Line/Area Cleaning, Preparation, and Clearance

211.67(b)(5) Do written procedures detail how equipment is to be checked immediately prior to use for cleanliness, removal of any labels and labeling from prior print operations? 211.67(b)(3) Do written procedures detail any disconnection and reassembly required to verify readiness for use?

6.3
6.301 6.302 6.303 6.304

Operational Process Validation and Production Change Order Control

Have production procedures been validated? (Review selected procedures for validation documentation. Adequate?) 211.100(a) Does the process control address all issues to ensure identity, strength, quality and purity of product? 211.101(a) Does the procedure include formulation that is written to yield not less than 100% of established amount of active ingredients? 211.101(c) Are all weighing and measuring preformed by one qualified person and observed by a second person?

6.305 211.101(d) Have records indicated preceding policy been followed by presence of two signatures? 6.306 6.307 211.103 Are actual yields calculated at the conclusion of appropriate phases of the operation and at the end of the process? 211.103 Are calculations performed by one person? Is there independent verification by a second person?

6.4

In-Process Inspection, Sampling, and Laboratory Control

211.110(a) Are written procedures established to monitor output and validate the performance of 6.401 manufacturing procedures that may cause variability in characteristics of in-process materials and finished drug products? 6.402 211.110(c) Are in-process materials tested at appropriate phases for identity, strength, quality, purity and are they approved or rejected by Quality Control?

211.160(b) Are there laboratory controls including sampling and testing procedures to assure 6.403 conformance of components, containers, closures, in-process materials, and finished product specifications?

6.5

Reprocessing/Disposition of Materials

6.501 211.115(a) Do written procedures identify steps for reprocessing batches?

6.502

211.115(b) Are quality control review and approval required for any and all reprocessing of material?

6.503 Does testing confirm that reprocessed batches conform to established specification? 6.504 6.505 Does a written procedure outline steps required to reprocess returned drug products (if it can be determined that such products have not been subjected to improper storage conditions?) Does Quality Control review such reprocessed returned goods and test such material for conformance to specifications before releasing such material for resale?

7.0 Finished Product Control

7.1
7.101 7.102

Finished Product Verification, Storage, and Handling

211.30 Do written procedures indicate how and who verifies that correct containers and packages are used for finished product during the finishing operation? 211.134(a) In addition, do written procedures require that representative sample of units be visually examined upon completion of packaging to verify correct labeling?

7.103 211.137(a) Are expiration dates stamped or imprinted on labels? 7.104 211.137(b) Are expiration dates related to any storage conditions stated on the label? 7.105 7.106 211.142(a) Are all finished products held in quarantine until QC has completed its testing and releases product on a batch to batch basis for sale? 211.142(o) Is finished product stored under appropriate conditions of temperature, humidity, light, etc.

7.2
7.201 7.202 7.203

Finished Product Inspection, Sampling, Testing, and Release for Distribution

211.166 Has the formulation for each product been tested for stability based on a written protocol? (Containers must duplicate those used in final product packaging.) 211.166 Are written sampling and testing procedures and acceptance criteria available for each product to ensure conformance to finished product specifications? 211.170(a) Is a quantity of samples equal to at least twice the quantity needed for finished product release testing maintained as a reserve sample?

7.204 211.167(a) Are sterility and pyrogen testing performed as required? 7.205 7.206 211.167(b) Are specific tests for foreign particles or abrasives included for any ophthalmic ointments? 211.167(c) Do controlled release or sustained release products include tests to determine conformance to release time specification?

7.3
7.301

Distribution Controls
211.150(a) Does a written procedure manage stocks to ensure that oldest approved product is sold first?

7.302 211.150(a) Are deviations to the policy above documented? 7.303 211.150(a) Does a written procedure identify the steps required if a product recall is necessary? 7.304 Is the recall policy current and adequate?

7.4
7.401

Marketing Controls
The current regulation does not address marketing controls per se except that all finished products must meet their specifications.

7.5

Complaint Handling and Customer Satisfaction Program

7.501

211.198(a) Are complaints, whether received in oral or written form, documented in writing and retained in a designated file?

7.502 211.198(a) Are complaints reviewed on a timely basis by the Quality Control Unit? 7.503 211.198(b)(1) Is the action taken in response to each complaint documented? 7.504 7.505 211.198(b)(3) Are decisions not to investigate a complaint also documented and the name of the responsible person documented? 211.198(b)(2) Are complaint investigations documented and do they include investigation steps, findings, and follow-up steps, if required? Are dates included for each entry?