Managerial procedures required to obtain the Good Manufacture, Distribution, and Storage Practice CertificateJune 30, 2021
Anvisa issued the Resolution of the Collegiate Board of Directors (RDC) 497/2021, in which it establishes the managerial procedures required to obtain the Good Manufacture Practice Certificate and the Good Distribution and/or Storage Practice Certificate.
The objective of this resolution is to establish the managerial procedures necessary to obtain the Good Practice Certificates for the Manufacture of Drugs, Health Products, Cosmetics, Perfumes, Personal Hygiene Products, Sanitizers, Active Pharmaceutical Ingredients, and Food, and the Good Practice Certificates for Activities of Distribution and/or Storage of Drugs, Health Products, and Active Pharmaceutical Ingredients to optimize and streamline the processes, bringing more transparency to the managerial procedures related to the Good Practice Certification.
Definition of the Resolution 497/2021
These are the definitions enacted by the resolution and its applications:
I- Storage: set of operations that comprise holding, handling, and guarding products and their related controls;
II- Good Distribution and/or Storage Practice Certificate (CBPD/A): document issued by Anvisa stating that given facility fulfills the Good Distribution and Storage Practice or the Good Storage Practice technical requirements, provided by the governing legislation and required for the product’s commercialization;
III- Good Manufacture Practice Certificate (CBPF): document issued by Anvisa stating that given facility fulfills the Good Manufacture Practice technical requirements, provided by the governing legislation and required for the product’s commercialization;
IV- Technical-operational conditions (CTO): classification applied in the Brazilian territory to facilities or production lines that are beginning their activities or to existing production lines when a new pharmaceutical form/risk class is added and which have proper technical and operational capacity to manufacture drugs or health products at industrial scale;
V- Distribution: set of activities related to the transfer of cargo that involves supplying, storing, and dispatching products, excluding direct sales to the public;
VI- Facility: unit responsible for the execution of one or more activities subject to certification;
VII- Manufacture: all operations necessary to prepare given product, including the acquisition of materials, production, quality control, release, storage, product dispatch, and related controls;
VIII- Form of acquisition: method through which the pharmaceutical ingredient is acquired;
IX- Pharmaceutical form: final presentation state of given pharmaceutical preparation after one or more executed operations, with or without the addition of excipients, to facilitate its use in given route of administration;
X- Biological active pharmaceutical ingredient: active allergen pharmaceutical ingredients, monoclonal antibodies, hemoderived products, microorganisms employed to produce probiotics, immunobiological products, and the active ingredients obtained through animal-originated biological fluids or tissues, including those obtained through biotechnological procedures;
XI – Good Manufacture Practice or Good Distribution and/or Storage Practice technical requirements necessary for the product’s commercialization: technical requirements recommended by the Good Manufacture Practice and Good Distribution and/or Storage Practice governing standards, developed through a risk-based approach that reflects a minimal level of fulfillment of the good practices, enough for the product’s commercialization;
XII- Applicant: a company, legally established in Brazil, that requires the Good Manufacture Practice Certificate and/or the Good Distribution and/or Storage Practice Certificate to the competent authority.
To whom it applies?
The resolution applies to companies that manufacture Drugs, Health Products, Cosmetics, Perfumes, Personal Hygiene Products, Sanitizers, Active Pharmaceutical Ingredients, and Food located in the Brazilian territory or in other countries and to companies that store, distribute, and import Drugs, Health Products, and Active Pharmaceutical Ingredients located in the Brazilian territory.
What are the main changes in comparison with the current legislation?
These are the main changes made by the resolution in comparison with the current legislation.
- Inclusion of the managerial procedure for the Good Manufacture Practice Certificate for the food category.
- With the issuance of the new RDC, the managerial procedures of the categories Drugs, Health Products, Cosmetics, Perfumes, Personal Hygiene Products, Sanitizers, Active Pharmaceutical Ingredients, and Food are included in a single RDC.
- List of information and reports that can subsidize Anvisa’s decisions regarding the certificate applications.
- Anvisa already uses information and reports, issued by other departments of the Brazilian Health Regulatory System (SNVS), by regulatory authorities and third-party auditing bodies to subsidize the decision regarding the Good Practice Certificate. Said list makes the managerial procedure clearer.
- Extension of the Good Distribution and/or Storage Practice Certificate’s validity term to four years.
- A greater validity term is established for the Good Distribution and/or Storage Practice Certificate, considering that there is less health risk involved in the performance of said activities and that said certificate is not mandatory. Therefore, it is a measure of regulatory impact minimization and of managerial load rationalization, without the addition of health risk.
- Possibility of not issuing additional certificates for different applicants when a valid certificate was already issued for the same facility, the same acquiring method, and the same active pharmaceutical ingredient, when the active pharmaceutical ingredient is obtained through chemical synthesis, classic fermentation, or semisynthesis.
- Clear estimation of when the certification applications can be overruled.
- Future publication, at Anvisa’s portal, of the facilities’ situation regarding the Good Practice Certificates and the legal base that led to the final decision.
To register any product, its characteristics and applications must be informed, according to the rules of this resolution, fulfilling the Good Manufacture Practice or Good Distribution and/or Storage Practice technical requirements; only then the product can be commercialized.
Find out more about the Resolution (RDC) 497/2021, clicking here.