A New Draft Guidance on FDA Expectations for Cosmetic GMP

Scott Sutton, Ph.D.
Microbiology Network, Inc.

 

There is a good deal of interest from FDA in the cosmetics industry and the Quality systems in place at manufacturing facilities.  The only published guidance, until recently, was the Good Manufacturing Practice (GMP) Guidelines/Inspection Checklist (originated February 12, 1997; Updated April 24, 2008).  This guidance situation has recently changed with the release of the draft Guidance for Industry Cosmetic Good Manufacturing Practices (released June 24, 2013).

The draft “Guidance for Industry” released late in June of 2013 is a complete rewrite of the previous guidance document.  This was much needed, as the previous document was in truth a training document for FDA inspectors preparing to audit a cosmetics manufacturer and not a “Guidance to Industry” in any real sense.  This recently released draft guidance brings both the document format and the GMPs in line with current FDA thinking.  However, it should be noted that FDA does not have GMP “requirements” per se for cosmetics manufacturing because GMPs are not included in FDA regulations.  Thus, while following cosmetic GMPs is voluntary, this draft guidance sets forth FDA expectations because it is intended to assist industry and other stakeholders in identifying the standards and issues that can affect the quality of cosmetic products.

The current document is organized into the following sections (with changes noted from the previous):

  1.  Introduction – Reasons for revisions to 2008 document
  2. Background – Role of ISO in setting cosmetic regulations
  3. Discussion
    1. Overview – legal authority of FDA from FD&C Act section 301 prohibts misbranded or adulterated cosmetics
    2. Definitions for commonly used words are provided
    3. Specific Guidance for Cosmetics
      1. Documentation
      2. Records
        Documentation and Records expectations are greatly expanded from the 2008 “Guide” which only included to briefest note that activities should be documented (see Section 7 “Records”).  This is an area where, in my consulting experience, cosmetics companies and their QC microbiology laboratories are especially vulnerable and this expansion of expectations by FDA should be evaluated against current practice.
      3. Buildings and facilities
        This section is completely rewritten from the “Guide” and introduces new expectations in terms of organization of materials to prevent mix-ups or cross-contamination, adequate pest control.  These specified expectation are in addition to those previously described in the “Guide”
      4. Equipment
        The “Guide” focused on equipment maintenance, sanitizing, and suitability.  To these expectations the draft guidance also discusses the need for calibration of equipment and how to deal with defective or out of tolerance equipment.
      5. Personnel
        In addition to the expectation that personnel should have adequate education and training for their job responsibilities, be appropriately gowned and be allowed to eat or smoke only in appropriate areas, the draft guidance also expects workers to be free of illness and open sores (sources of microbial contamination), be properly supervised while in the manufacturing facility, and that the company should control access to production, storage and product control areas.
      6. Raw Materials
        There are no significant changes in expectations between the 2008 “Guide” and the draft “Guidance” in the general discussion.  However, the draft “Guidance” expands this section significantly with specific discussions of:

        1. Water – the quality of water used for production needs to be stated and controlled, is being monitored, and that the “entire system for supplying water used as a cosmetic ingredient is set up to avoid stagnation and risks of contamination (This system should be routinely cleaned and sanitized according to an appropriate SOP that ensures minimal biofilm build-up).
        2. Color Additives – Must be on FDA’s approved list for use for the specific product
        3. Prohibited and Restricted Cosmetic Ingredients – an abbreviated table of prohibited and restricted ingredients is provided, with instruction to confirm these against the list maintained on the FDA website.
      7. Production
        Both versions of the FDA Cosmetic GMPs stress the importance of establishing written SOPs to control procedures. In general, the 2008 “Guide” seems to be more explicit that the 2013 draft, possibly allowing greater scope for different approaches.  The draft “Guidance” expands this section – requiring that the tamper-resistant packaging and labeling for liquid oral hygiene products and vaginal products meet regulatory requirements as well as to ensuring that the storage and handling of packaging materials that come into direct contact with the product prevent selection errors and microbiological or chemical contamination.
      8. Laboratory Controls
        There are few changes in these expectations between the versions except the explicit instruction that the samples tested must be representative, that raw materials and finished product are tested for microbial quality.   A formal stability program continues to be expected.  In addition, raw material, in-process and finished product testing for all specifications remains a GMP requirement.
      9. Internal Audit
        This is a new expectation in the 2013 draft.  The expectations for these audits is that:

        1. There is a procedure specifying either regular or in-demand audits
        2. Auditors are not directly responsible for the area being audited
        3. Audit findings are reviewed by management and all stakeholders
        4. Follow-up occurs to ensure correction of audit findings.
      10. Complaints, Adverse Events, and Recalls
        This is another new expectation in the 2013 draft.  This section includes discussion of complaints, complaints alleging adverse events involving bodily injury, and specific expectations and additional regulatory guidance on product recalls.  These expectations are very different from the 2008 “Guidance” which was restricted to complaints involving injury and the reporting of those injuries.
      11. Labeling
        Labeling, as such, is not addressed as a separate section in the 2013 draft although it so appeared in the 2008 guidance for inspection.   This topic is addressed in several sections of the draft as appropriate.

Comments and Conclusions

The 2013 draft guidance for industry (11 pages) is more detailed and extensive than the 2008 inspection guide (5 pages).   The impact of ISO documents (especially ISO 22716 (Cosmetics – Good Manufacturing Practices (GMP) – Guidelines on Good Manufacturing Practices. ISO 22716:2007) on this draft is clear, and it will be helpful to have a unified expectation for GMPs in the cosmetic industry.  It should also be noted that the Personal Care Products Council (PCPC) has also adopted ISO 22716 as guidance and has presented an extensive commentary on GMP for the cosmetics industry (CTFA Quality Assurance Guidelines 2007).

It is in the best interest of all cosmetic manufacturers that they be aware of FDA expectations in the personal care arena.  Many of these companies also manufacture OTC products, and the expectations of the draft guidance will already be familiar as FDA moves the cosmetics industry closer to the quality and control expectations found in the manufacture of pharmaceutical products.

If your company has comments on this draft, they should be submitted to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. All comments should be identified with the title of the guidance document.

One comment

  1. Timothy says:

    .

    tnx for info.