21CFR 111

Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements

The Food and Drug Administration (FDA) has issued a final rule regarding current good manufacturing practice (CGMP) for dietary supplements. The final rule establishes the minimum CGMPs necessary for activities related to manufacturing, packaging, labeling, or holding dietary supplements to ensure the quality of the dietary supplement. The final rule is one of many actions related to dietary supplements being taken to promote and protect the public health.

21CFR 111 applies to both domestic and foreign companies that manufacture, test, package, label, hold, or distribute dietary supplements in the United States. Compliance enforcement to the regulation will be phased in, based on company size, over 3 years.

Compounding Pharmacy

USP<797> (Pharmaceutical Compounding – Sterile Preparations) became effective in 2004. 460.200 – Pharmacy Compounding Guidance was issued by FDA in 2002. The FDA has issued Warning Letters to pharmacy compounding facilities in violation of requirements outlined in <797> and 460.200, and FDA oversight of compounding facilities has increased. GQA can provide expertise in auditing to meet these requirements as well as design and develop procedures, systems, and facilities.


A list of tests, references to analytical procedures, and appropriate acceptance criteria that are numerical limits, ranges, or other criteria for the tests described. It establishes the set of criteria to which a drug substance should conform to be considered acceptable for its intended use.

Conformance to specifications means that the drug substance, when tested according to the listed analytical procedures, will meet the listed acceptance criteria.

Specifications are binding quality standards that are agreed to between the appropriate governmental regulatory agency and the applicant.

(ICH draft guidance Q6A Specifications: Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances)

FDA Form 483

A listing of observations of objectionable conditions and practices, pursuant to Section 704(b) of the Federal Food, Drug, and Cosmetic Act, to assist firms in complying with the Acts and regulations enforced by the Food and Drug Administration. This listing is presented to the highest management official available upon completing an inspection and before leaving the premises.

FDA Form 482

A written, signed Notice of Inspection issued to a firm by an FDA Investigator who has the authority to enter and inspect a firm operating at a business location.

The Food and Drug Administration (FDA)

The FDA is an agency of the United States Department of Health and Human Services and is responsible for regulating food, dietary supplements, drugs, biological medical products, blood products, medical devices, radiation-emitting devices, veterinary products, and cosmetics in the United States

ICH Q9: Quality Risk Management

The ICH Q9 guideline provides principles and examples of tools of quality risk management that can be applied to all aspects of pharmaceutical quality including development, manufacturing, distribution, and the inspection and submission/review processes throughout the lifecycle of drug substances and drug (medicinal) products, biological and biotechnological products, including the use of raw materials, solvents, excipients, packaging and labeling materials.

Continuous Quality Improvement (CQI)

A key component of continuous quality improvement is reliable, accurate auditing of the people, processes and technologies used to manufacture pharmaceutical and biotechnology products.

Quality Systems Assessments

Utilizing defined audit methods for quality systems assessments, we are able to fairly evaluate your quality practices. We identify
opportunities that enable you to achieve, maintain and improve quality in your operations.

Quality Assurance

A planned and systematic set of activities to ensure that requirements are clearly established and the defined process complies to these requirements.

This includes activities to ensure that variances in processes are clearly identified, assessed and improved.

For drug products, these activities and actions are necessary to assure that the product meets all requirements as to strength,purity, and efficacy.