All comments can be sent at [email protected] Deadline of submission of comments shall be by 08 October 2021.
Republic Act (RA) No. 3720, as amended by RA No. 9711, declared it a policy of the State to adopt, support, establish, institutionalize, improve and maintain structures, processes, mechanisms and initiatives that are aimed, directed and designed to help establish and maintain an effective health products regulatory system. Pursuant to the foregoing policy, the State, through the Food and Drug Administration, must enhance its regulatory capacity and strengthen its capability with regard to the inspection, licensing and monitoring of establishments, and the registration and monitoring of health products.
Consequently, and in order to achieve the objective of RA No. 9711 of ensuring the FDA’s monitoring and regulatory coverage over, and providing coherence in FDA’s regulatory system for drug establishments and drug products, it is imperative that classification of deficiencies noted during inspection of drug distributors and drug retail outlets is consistent, and guided with distribution and storage practices considered non-compliant to FDA-implemented rules/ standards in the distribution of drug products.
Finally, in compliance with the declared policy of the State laid down in Republic Act No. 11032 or the Ease of Doing Business and Efficient Government Service Delivery Act of 2018 to promote integrity, accountability, establish effective practices, aimed at efficient turnaround of the delivery of government services and the prevention of graft and corruption in government, the FDA is committed to take appropriate measures to promote transparency.
Hence, this Circular is hereby issued.
This Circular is issued to have uniform understanding in the classification of the noted non-conformances during inspection of drug distributors and drug retail outlets and provide guidelines to the drug GDSP inspectorate service of the FDA’s Field Regulatory Operations Office. , as well as drug distributors and drug retail outlets for uniformity of regulatory understanding consistent with the provisions of RA No. 3720, as amended by RA No. 9711, RA No. 11032, and relevant national and international standards and policies.
These guidelines shall apply to all drug Good Distribution and Storage Practice (GDSP) inspectorate and local drug establishments distributing and retail of drugs including: household remedy, medicinal gas, traditional and herbal medicines, non-sterile, sterile, vaccines and biologicals and active pharmaceutical ingredients for human and animal use.
For uniformity, efficiency and transparency, non-conformances observed during inspections are classified based on the following definitions:
1. Critical deficiency – is a departure from the GDSP Guide that leads to a significant risk to the patient or public health. It also refers to a serious situation that could result in regulatory action being considered.
A deficiency is also considered critical when the establishment is observed to be engaged in fraud, misrepresentation or falsification of pharmaceutical products or data documents.
2. Major deficiency – is a deficiency which indicates a major deviation from Good Distribution and Storage Practices that has a “direct effect” in the quality/ efficacy of pharmaceutical products.
A combination of several “other” deficiencies, none of which may be major, but which together present a major deficiency and should be explained and reported as such.
3. Others – a deficiency that is not classified as either “Critical” or “Major”, but indicates a deviation from GDSP or a deficiency may be judged as “Other” because there is insufficient information to classify it as “Critical” or “Major”.
For reference, a list of observations classified according to the above definitions is attached as Annex A. The list is non-exhaustive and other observations may be added, removed, or re-classified as appropriate, subject to notice to the concerned stakeholders.
In case of findings classified as critical deficiency (ies) the establishment is directed to initiate outright, any or all of the following (depending on the assessed degree of risk to patient safety):
a. Temporarily stop distribution of affected products
b. Undertake or cause company-initiated recall of affected batches following existing FDA rules and procedure for product recall;
c. Address the deficiencies, including submission of Corrective Action and Preventive Action (CAPA) plan and objective evidence of compliance, not later than fifteen (15) calendar days reckoned on the day following the receipt of the inspection report.
Apart from the foregoing, critical findings may result in the FDA imposing subsequent regulatory action, including disapproval of application, suspension or revocation of the issued authorizations.
In case of major and other deficiencies, the inspector is authorized to direct the establishment to address the deficiencies, including the submission of CAPA Plan and objective evidence of compliance, not later than fifteen (15) calendar days reckoned on the day following the receipt of the inspection report.
V. REPEALING AND SEPARABILITY CLAUSES
Any provisions of existing FDA-issued Circulars or Memoranda that are inconsistent with this Circular are hereby repealed, withdrawn and/or revoked accordingly.
If any provision of this Circular or application of such provision to any circumstances is held invalid, the validity of the remainder of the provisions hereof not affected shall continue to be in effect.
This Circular shall take effect immediately.