As per 21 CFR part 211, no any clause regarding ‘Self inspection’ is included. Which guideline of FDA covers the Self inspection topic ? Can anybody help pls. providing the link of FDA guideline ?
Self-inspections, while not mandated by the FDA, are a valuable tool for companies to ensure compliance with regulatory requirements and improve their quality systems. They involve internal audits to identify potential issues and implement corrective actions before they become major problems, ultimately reducing the risk of FDA non-compliance.
Regulations for self-inspections and internal audits are a little bit different in the US and the EU. For example, if you delete your internal audit report after the CAPA plan was closed, then you would be compliant with the FDA regulations, but not with the rules in the EU. It is important to realise that the US cGMP regulations (21 CFR Parts 210 and 211) do not describe specifically a requirement to conduct and keep records of an internal quality assurance audit, which is not the case with the EU-GMP guideline. Besides the American and the European regulations more information about self-inspections can be found in the WHO requirements and in the PIC/S guidelines.
As per PIC’s guidelines, the following are the principles of self-inspection.
PHARMACEUTICAL INSPECTION CONVENTION
PHARMACEUTICAL INSPECTION CO-OPERATION SCHEME
PE 009-17 (Part I)
25 August 2023
GUIDE TO GOOD MANUFACTURING
PRACTICE FOR MEDICINAL PRODUCTS, PART I
CHAPTER 9 - SELF-INSPECTION
PRINCIPLE
Self-inspections should be conducted in order to monitor the implementation and
compliance with Good Manufacturing Practice principles and to propose
necessary corrective measures.
9.1. Personnel matters, premises, equipment, documentation, production, quality
control, distribution of the medicinal products, arrangements for dealing with
Complaints and recalls, and self-inspection, should be examined at intervals
following a pre-arranged programme in order to verify their conformity with the
Principles of Quality Assurance.
9.2. Self-inspections should be conducted in an independent and detailed way by
designated competent person(s) from the company. Independent audits by
external experts may also be useful.
9.3. All self-inspections should be recorded. Reports should contain all the
observations made during the inspections and, where applicable, proposals for
corrective measures. Statements on the actions subsequently taken should also
be recorded.
Also, as per the Schedule M in Indian Drug Rules under the Drugs and Cosmetics Act it is mandatory to conduct self-inspections.
The purpose of self-inspection is to evaluate the manufacturer’s compliance with good manufacturing practices in all aspects of production and QC. The self-inspection programme shall be designed to detect any shortcomings in the implementation of good manufacturing practices and to recommend the necessary corrective actions. Self-inspections shall be performed routinely, and may be, in addition, performed on special occasions e.g., in the case of product recall or repeated rejections, or when an inspection by the regulatory authorities is announced. The team responsible for self-inspection shall consist of personnel who can evaluate the implementation of good manufacturing practices objectively.
All recommendations for corrective action shall be implemented. The procedure for self-inspection shall be documented and there shall be an effective follow-up programme.
Items for self-inspection-Written instructions for self-inspection shall be established to provide a
minimum and uniform standard of requirements. These may include questionnaires on good
manufacturing practices requirements covering at least the following items, namely:-
(a) personnel;
(b) premises including personnel facilities;
(c) maintenance of buildings and equipment;
(d) storage of starting materials and finished products;
(e) equipment;
(f) production and in-process controls;
(g) quality control (QC);
(h) documentation;
(i) sanitation and hygiene;
(j) validation and revalidation programmes;
(k) calibration of instruments or measurement systems;
(l) recall procedures;
(m) complaints management;
(n) labels control; and
(o) results of previous self-inspections and any corrective steps taken.