Good Manufacturing Practices (GMP) Requirements for ...
Good Manufacturing Practices (GMP) Requirements for Cosmetics
in USA
July 2020
TABLE OF CONTENTS
Overview Definitions Specific guidance for cosmetics Production Laboratory controls Internal audit Complaints, adverse events and recalls
Part 1: Applicable
FDA Regulations
FDA Regulations & Guidance
The Federal Food, Drug and Cosmetic Act (the FD&C Act) prohibits the introduction, or delivery for introduction, into interstate commerce of cosmetics that are adulterated or misbranded (Section 301 of the FD&C Act).
Guidance for Industry: Cosmetic Processors and Transporters of Cosmetics Security Preventive Measures Guidance."
Part 2: Definitions
Definitions
Terms
Definitions
Documentation:
Good manufacturing practice (GMP):
Internal Audit
The supplying of documents or supporting references; use of documentary evidence; the documents or references thus supplied; the collecting, abstracting, and coding of printed or written information for future reference
That part of quality assurance aimed at ensuring that products are consistently manufactured to a quality appropriate to their intended use. It is thus concerned with both manufacturing and quality control procedures.
Systematic and independent examination made by competent personnel inside the company, the aim of which is to determine whether activities covered by these guidelines and related results comply with planned arrangements and whether these arrangements are implemented effectively and are suitable for achieving objectives.
Standard operating Instructions on how to perform tasks and descriptions of the approved or required procedures for
procedure (SOP)
accomplishing specific quality assurance objectives
Part 3: Documentation Requirements
Requirements for Documentation
Documentation should:
Create a mechanism that shows how products are manufactured and tested. Defines the organization's processes and capture every aspect of the
manufacturing process. Prevents errors of interpretation or loss of information that may result from
reliance on verbal communication. Allows to trace where any problems may have occurred and to take
appropriate corrective action.
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