5 Issues That Are Preventing Manufacturers From Becoming GMP Compliant
The Food and Drug Administration (FDA) is responsible for oversight of the industry and has the job of monitoring the marketplace for dietary supplements that may be unsafe to consume or products that make false or misleading statements about its benefits. Some of its activities include conducting audits of dietary supplement manufacturers, distributors, the Internet, obtaining consumer and trade complaints and occasional laboratory analysis of selected products.
Initiated in 2007 for consumer protection, the FDA-designed Current Good Manufacturing Practices (cGMPs) were implemented over a three-year period. According to the FDA, the cGMPs will “assure quality is built into the design and manufacturing process at every step.” 1 To show that it means business, since 2007, the FDA has increased GMP audits each year. In 2010 the number of audits was 84; as of May 2011 the number of audits that have taken place is 66. FDA enforcement activities include inspections, consumer warnings, product recalls, product seizures and criminal investigations. Warning letters may or may not be issued before such action is taken.
The FDA has identified a long list of cGMP non-compliance failures that have been committed over the years, but here are the 5 issues that are preventing manufacturers from becoming GMP Compliant: 2
1. Failure to perform the required testing for identifying raw materials.
The cGMPs require that both raw materials and finished product undergo laboratory testing as a critical part of the production process. To this end, all suppliers must meet specifications defined by the nutraceutical manufacturer whether it is for raw materials, equipment, reagents or other ingredients. Manufacturers must establish parameters for supplier qualification and conduct supplier audits to ensure accuracy of Certificate of Analysis (CoA).
The most common mistake is a discrepancy in labels. Independent tests show that actual ingredients found inside the supplement may not meet what is stated on the label. The supplement manufacturer failed to either test the raw material properly or specify clearly the composition of the finished product. Each raw material and finished product should have clear specifications. A CoA should accompany each raw material containing a description of the appropriate identification test methods, the limits of the test and results.
Laboratory facilities may be in-house or sent to a contract analytical lab. In either case, the facilities must be adequate to perform the necessary tests and examinations. The laboratory must keep complete records that are easily accessible for audits. In-house methods for testing can be put through a formal validation process that demonstrates the test’s ability to produce reliable results, repeatedly.
2. Failure to prepare written documentation for Standard Operation Procedures, Master Manufacturing Records and/or Batch Production Records.
The second most common mistake that disqualifies manufacturers from GMP compliance is inadequate Master and Batch records. A complete set of instructions for making and testing a product, known as the Master Manufacturing Record (MMR), must be set up. Master records from the overall processes for each product must be maintained with a Batch record that corresponds to the information on the Master record for each batch that is manufactured. The Batch record provides the necessary documentation that ensures that each step in the MMR was performed and the finished product meets pre-defined specifications in order for it meet GMP-compliance standards. Quality control personnel must verify each step before the product is released from the manufacturing unit.
Maintenance and storage of written records should be maintained for a pre-defined period. Electronic maintenance of records should comply with 21CFR11.
3. Failure to Uphold Quality Control (QC) Processes
Quality Control is a fundamental component of GMPs. However, this is one area commonly found by audits to be deficient. Personnel in charge of the QC process are responsible for ensuring the manufacturing, packaging, labeling and storage facilities all comply with GMP’s.
Problem areas include laboratory testing methods which do not use scientifically valid analytical methods, nor follow written procedures. According to the cGMPs, specifications for all materials should be defined and the methods used to establish those specifications should be available at audits. In addition, supplements, including vitamins, must adhere to the limits that have been set on contaminants in finished products.
Additionally, your manufacturing facility and equipment must be designed to meet cGMP standards and meet predefined specifications. Maintenance logs must be prepared and routinely maintained under the required hygienic conditions.
4. Failure to provide quality personnel to conduct material reviews and make disposition decisions
Each staff member must have the necessary qualifications for the job and/or experience to perform their functions. Personnel should be trained to conduct the manufacturing process in accordance with written standard operating procedures (SOPs). SOPs should be updated when processes change and the relevant personnel must be trained for their specific jobs and supervised. Written procedures for the QC operation must also be followed stringently and need to include procedures for conducting a material review and making a disposition decision as well as procedures for approving or rejecting any reprocessing.
Any violation of the SOPs along with corrective measures taken should be documented. Compliance to SOPs should be documented on checklists or forms and this should be evaluated periodically.
5. Failure to Set Up an Efficient Quality Assurance (QA) Department
Quality Assurance is a management function that systematically monitors and evaluates various aspects of a manufacturing facility and its processes. The Quality Assurance (QA) department works independently to audit all functions, maintain adequate documentation and train personnel. When deficiencies are identified, the QA department should define corrective and preventive steps that need to be taken. The goal is to maximize quality standards and ensure that a dietary supplement meets established specifications for identity, purity, strength and composition.
How You Can Be on Top of GMP-Compliance?
Despite the large amount of buzz regarding instances of cGMP non-compliance, there are supplement manufacturers who have demonstrated their commitment to high-quality manufacturing and have been proactively producing safe supplements. Asking your supplement manufacturers a few pertinent questions could help you identify contract manufacturers that stringently work within a GMP-certified manufacturing facility, and therefore provide a safe and reliable solution for your manufacturing needs.
- Have you seen your prospective or current supplement manufacturer exhibit at trade shows?
- Have you taken a tour of the manufacturing facility of your prospective or current supplement manufacturer?
- Can your prospective or current supplement manufacturer provide you with references of past customers?
- Does your prospective or current supplement manufacturer hold a good reputation for high-quality supplement manufacturing in the industry? Check out their awards and whether members in the community have heard of the manufacturer and what they have to say.
- Have they been 3rd party certified by a recognized cGMP certifying body (i.e. NSF)?
Because it is crucial to the survival and success of your supplement business, take time to choose a GMP-certified manufacturer who is experienced in the trade, can keep you abreast of the latest rules, regulations and manufacturing trends, and most importantly, partner with you long term producing high-quality supplements for your consumer market.