Ever thought about submitting your good manufacturing practices to third-party assessment, but aren?t sure how to go about it? Mike Schmidt highlights some of the frequently asked questions about GMP registration and provides some useful answers
Why should a manufacturer or a contract manufacturer of functional foods/supplements consider third-party good manufacturing practice registration, and what value does it provide?
The answer is simple: credibility. If you?re a contract manufacturer of functional foods or dietary supplements, how do you provide assurance to potential customers that your GMPs are up to snuff? You could show existing or prospective customers your last regulatory inspection if you had one, but most companies are not even audited on a three-year basis.
Manufacturers are ultimately responsible for compliance of the product with the proposed GMPs. Under the Food & Drug Administration?s GMP regulations for food and under the industry draft GMPs submitted to the government several years ago, the manufacturer is ultimately responsible for the integrity of the dietary supplements/functional foods it manufactures and the ingredients that go into them.
Recent reports indicate a wide variance in the quality of dietary supplements and functional foods, and have raised a number of important questions:
- How can a contract customer or the public be assured that the products it purchases are produced by a manufacturer living up to the highest GMP standards?
- Is the kind of programme in place that assures consistent quality production?
- What about shipping products internationally? Does the product documentation (batch records) measure up? Does it provide traceability?
- Is there a properly functioning recall procedure in place, and is it tested periodically?
- How are complaints handled? Is there investigation and documented follow-up?
These are just a few things that a third-party audit by a qualified and knowledgeable auditor will access.
Who does a manufacturer contact to obtain the services of a highly experienced third-party auditor, and what standards are you expected to meet?
There are a number of organisations and well-qualified individuals engaged in performing such audits. Among the best-qualified organisations are NSF International, the National Nutritional Foods Association and United States Pharmacopeia. Individuals are harder to access and their credentials and references should be judged carefully. Always ask for client references that can be checked. Do they have a checklist and can you receive a copy before the audit so you know ahead of time what is expected of you throughout the audit?
On the subject of standards, only NSF International has developed a true consensus standard, which is known as NSF/ANSI Standard 173. The NSF American National Standard is based on the FDA?s proposed GMPs for dietary supplements/ingredients. These GMPs are not yet legislation, but will be soon. NSF/ANSI Standard 173 will be amended taking into consideration any changes the FDA makes at the time of issuance.
NSF International has also published a certification guide for functional foods, which is based on the FDA?s Food GMPs (CFR Title 21, Section 110), along with other sources such as the American Pharmacists Association and the National Labeling and Education Act of 1990. This guide may well be a standard in the near future. Other organisations have developed their own requirements based on similar criteria and their experience.
If you are going to contract with an organisation to conduct a third-party audit of your facility and certify it as being GMP compliant, you will want to contract with an organisation that is well recognised and well respected.
If your company is located abroad and you wish to export food products and/or dietary supplements/ingredients, a third-party GMP audit and registration can be especially helpful, as your company name may not be that well known. Again the concern on the part of the customer is:
- Does this company comply with our country?s GMP standards?
- Can I trust the quality of the product we import is of a high level and consistent?
- Is the auditor, which the third-party certifying organisation is assigning to conduct the audit, well qualified?
- Do they have the education, proper training and experience to properly access your operation against the applicable standards? And will they take into consideration that these requirements may vary depending on where the audit is conducted?
Under the regulations recently adopted by Canada and as applied by the Natural Health Products Directorate (NHPD), there are certain standards that require third-party auditors and also standards for your in-house quality assurance staff. If you wish to import a new natural health product into Canada, you will need to be aware of these requirements and timelines (for more information, log onto: www.healthcanada.ca).
You will also require a quality report as part of the process for obtaining a site licence and product licence. NHPD Canada has recognised third-party GMP audits by registered auditors. It also participated in the development of NSF/ANSI Standard 173 for dietary supplements.
What does it cost to obtain a third-party GMP audit, and how should you prepare for it?
The costs will vary from organisation to organisation. Fees associated with audits are usually based on the size of the facility, number of employees involved in production and the number/location of production facilities. Once you obtain GMP registration, there may be some future costs to maintain the registration.
Other costs you may incur can be classified as preparation costs. After receiving the standard to be used and the checklist, there may be items identified that you need to upgrade prior to the actual audit. Some organisations offer a one-day, pre-audit visit to help a client better identify those areas in need of improvement. For example, if you find that your facility is lacking some needed standard operating procedures, you may want to assign a member of your team to write them. This is not an out-of-pocket expense, but it is an expense because it involves staff time.
The public, and hence contract customers, is well aware of the problems surrounding unsafe food products and dietary supplements that find their way into the news. Indeed, any company that manufactures a product recognises the vagaries that can occur. We all rely on risk-management techniques to control our processes and still produce an affordable product, and third-party GMP registration is an effective tool that does just that.
Can third-party GMP registration be leveraged and reduce costs?
Yes. If you are a manufacturer of functional foods products or dietary supplements/ingredients, you are probably subject to numerous customer audits that can be disruptive and take copious staff time to accompany the various customer representatives.
Third-party GMP registration avoids this. The customer, in order to demonstrate and perform due diligence, spends staff time and experiences travel costs to perform these audits. Its representative may or may not be knowledgeable and trained to handle these audits. If you provide them with GMP facility registration, it may be possible for you and your customer to construct a ?win-win? situation that works for both parties.
Canada?s NHPD has incorporated into its regulatory process the ability to accept a qualified audit as part of the required quality report. In the US, achieving independent third-party GMP registration will help a company be better prepared to meet FDA GMPs once they become a final rule.
The bottom line is that a rigorous third-party audit and GMP registration will add to your credibility, with both potential and current customers. It will give you an accurate picture of your state of GMP compliance and yield hidden benefits in the form of offering you and your customers the opportunity to reduce costs without reducing assurance/diligence.
Like many other programmes, it is no panacea or fail-safe guarantee. However, it is going the extra mile by positioning you a step above the competition in the battle for customers? trust and hence their business.