GMP Finished Pharmaceutical : General Provision

SCOPE   

(a)    The regulations in this part contain the minimum current good manufacturing practice for preparation of drug products for administration to humans or animals.

(b)    The current good manufacturing practice regulations in this chapter, as they pertain to drug products, and in Parts 600 through 680 of this chapter, as they pertain to biological products for human use, shall be considered to supplement, not supersede, the regulations in this part unless the regulations explicitly provide otherwise. In the event, it is possible to comply with applicable regulation both in this part and in the other parts of this chapter or in parts 600 through 680 of this chapter, the regulation specifically applicable to drug product in question cell supersede the regulation in this part.

(c)    Pending consideration of a proposed exemption published in the federal register of September 29, 1978, the requirements in this part shall not be enforced for OTC drug products if the products and all their ingredients are ordinarily marketed are consumed as human foods, and which products may also fall within the legal definition of drug by virtue of their intended use. Therefore, until further notice, regulation under part 110 of this chapter, and where applicable , parts 113 to 129 of this chapter, shall be applied in determining whether this OTC drug products that are also foods are manufactured, processed, packed, or held under current good manufacturing practice.

DEFINITIONS :
    This section states that the company’s adherence to the requirements of the entry set of regulation determined whether its output will be judged as adulterated or violative. Adherence to the requirements initially necessitates an analysis of all current operations within the company that if a fact the quality of the finished products. Such an analysis surveys as a framework for structuring decision and information follows between managers, operators, scientists, technicians, and other personnel who regulate product quality. An analysis of current conditions also divides the flow of materials into discrete, sequential operations from the receipt and sampling of raw materials to final accountability computations during the market distribution, in order that critical procedures can be specified and more closely examined.
   
The first step is to evaluate the chances of establishing and maintaining a god quality control program. The first list, therefore, is a description of the organization.

Product Information: In order to initiate quality control procedures, the dimensions of operations should be estimated. This requires the following information for the entire product line of the firm

Type and        Quality                Quantity Packaged       

Product name    Manufactured          Own label        Other label

Tablets
Tablets, coated
Tablets, multiplayer
Tablets, enteric coated
Tablets, repeat dosage
Tablets, sustained release
Capsules
Capsules, sustained release
Liquids, external
Liquids, oral
Liquids, oral, sustained release
Ophthalmic solutions
Parenteral, sterile fill
Parenteral, sterilized
Syringe, prefilled
Suppositories
Granules, oral
Powders
Aerosols
Aerosols, metered dose
Sterile dressings   
   
How are the products promoted? (Obtain samples and package inserts.) _____ Professional journal ______ Lay journal _____ Internet _____ Newspaper ______ Other.

    The same procedures should be followed in assessing the operations of all outside contractors who contribute to the production of the finished pharmaceutical.

    Attention should be focused on the critical concepts of a quality control system. The production cycle for each drug must be controlled so that optimum quality levels can be attained for each manufacturing sequence. The efforts of all personnel making product integrity decisions during processing must be coordinated and standardized to attain these desired levels.

SUPPLEMENTARY INFORMATION AS TO CGMPS FOR MEDICAL DEVICES AS PROVIDED BY FOOD AND DRUG ADMINISTRATION :

Manufactures establish and follow quality systems to help ensure that their products consistently meet applicable requirements and specifications. The quality systems for FDA regulated products (food, drugs, biologics. And devices) are known as CGMPs. CGMP requirements for devices (part 820 (21 CFR part 820)) were first  authorized by section t520(f) of the Federal Food, drug and Cosmetic Act (the Act) (21 U.S.C. 360j(f)), which was among the authorities added to the Act by the Medical Device Amendments of 1976 (Pub L. 94-295). The Safe Medical Devices Act (the SMDA) of 1990 (Pub. L.101-629), enacted on November 28, 1990, amended section 210(f) of the Act, providing FDA with the explicit authority to add preproduction design validation controls to the CFMP regulation. The SMDA also added a new section 803 to the Act (21 U.S.C. 393) which, among other things, encourages FDA to work foreign countries toward mutual recognition of CGMP requirements.

Requirements for Expiration Dating and Stability Testing
    Current Good Manufacturing Practices for Finished Pharmaceuticals (CGMP) introduced requirements concerning expiration dating  and stability testing  which became effective September 29, 1979. The purpose of this guide is to delineate those situations in which the Center is prepared to consider regulatory action.

POLICY :

1.    Lack of assurance that a product labeled as sterile has been tested to ascertain that the container and closure can maintain a sterile state throughout the labeled shelf life.
2.    Lack of a written stability program for bulk drug substances or an indication that it is either inadequate or not being followed.
3.    Lack of an expiration date on finished dosage forms or a written stability program.
4.    Lack of a labeled date indicating stability after reconstitution or lack of studies to support the appropriateness of that date.
5.    Lack of an ongoing testing program to verify product stability after the shelf life has been determined appropriate.
6.    Lack of assurance that meaningful, specific, or reliable test methods and storage conditions are employed.
7.    Lack of assurance that the currently marketed container or closure will provide adequate protection of the drug product.
8.    Lack of follow-up studies at the labeled storage condition or, if there are no storage conditions specified, at room temperature, for drug products for which the shelf life was determined by accelerate studies.
9.    Lack of assurance of the effectiveness of any preservations used throughout the labeled shelf life.
10.    Lack of an adequate number of batches (i.e. less than three) employed as the basis for either confirming a tentative expiration date or establishing the long-term stability of the product.
11.    Distribution of product past the labeled expiration date.