The GMP Audit - Part 1  - Introduction:
by John F. Cuspilich, Sr. Consultant, The Auditing Group, Inc.

The Auditing Group, Inc. conducts over 200 GMP audits each year, and after a while we start to see common trends in normal standards and non-compliance issues from company to company.

In this section, we will look at the GMPs Title 21 Code of Federal Regulations (CFR) Part 211 (The Drug GMPs) and from an audit perspective, discuss each section as it applies to a on-site inspection.

Each week, we will publish a couple of the sections and talk in detail, about the implementation processes, and the "what, and what not", to do during an audit.

Each of the sections we publish will be used to create an audit check list for final use.  Use this check list as a self assessment tool and learn from your executions and deficiencies.  Remember, the GMPs is a 'risk-based' process, which needs to be assessed depending on many variables.  So, ensure you understand your risks before self assessing your compliance standings.

Before starting an on-site audit, plan the audit. Review past audits, note indications of possible problem areas and items, if any, that were identified for corrective action in a previous audit. If you are not already familiar with this facility, learn the type of product produced here and how it is organized by personnel and function. What does your "customer", i.e., your superior or senior facility management, expect to learn from this audit?

  1. The checklist is to be used along with a notebook into which detailed entries can be made during the audit. Ensure to capture issues contemporaneously as they occur or as you see them.  Attachments should be included within the notebook and reference notebook location of entries.
  2. While the checklist is to guide the auditor, is not intended to be a substitute for knowledge of the GMP regulations. Ensure that the auditor understands the GMPs as they apply to their industry.  It is also recommended to use outside 3rd. party assistance when conducting an initial GMP audit.
  3. Notebooks used should be a laboratory-type notebook with bound numbered pages. The notebook should be clearly labeled as to the audit type, date, and auditor(s). Use a notebook for a single audit so it may be filed with the checklist and the final report.
  4. The references to sections in the GMP regulation are for your convenience should a question arise. In some instances, two or more sections within the GMP regulation may have bearing on a specific subject. The headings in the GMP regulation will usually offer some guidance on the areas covered in each section.

SECTION 1.0 - General Controls


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

Yes, No, NA and Comments

1.0 - General Controls 


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



Organizational & Management Responsibilities



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



§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 contractor’s 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?



Document Control Program



§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?



§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?



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 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?



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?



§211.25 Are training records readily retrievable in a manner that enables one to determine what training an employee has received, which employees have been trained on a particular procedure, or have attended a particular training program?



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 adversely affect the safety or quality of drug products, from coming into direct contact with any drug component or immediate containers for finished product?



§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?



§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 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?



Plant Safety and Security



Does this facility have a facility or corporate safety program?



Are safety procedures written?



Are safety procedures current?



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, the type of training, the date of the training, and the name of the trainer and the signature of the trainer and the participant?



Does this facility have a formal, written security policy?



Is access to the facility restricted?



Describe how entry is monitored/restricted:



Is a security person available 24 hours per day?



Internal Quality/GMP Audit Program



Does this business unit/facility have a written quality policy?



Is a copy of this quality policy furnished to all employees?



If "yes" to above, when provided? __________________



Is training provided in quality improvement?



Does a formal auditing function exist in the Quality Assurance department?



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?



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



Quality Cost Program



Does this facility have a periodic and formal review of the cost of quality?



Does this facility have the ability, through personnel, software, and accounting records, to identify and capture quality costs?



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



End of Part 1