Home > NewsRelease > Adulterated Dietary Supplements – A Checklist for Complying with Current Good Manufacturing Practices (CGMP) for Dietary Supplements
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Adulterated Dietary Supplements – A Checklist for Complying with Current Good Manufacturing Practices (CGMP) for Dietary Supplements
From:
Tracy P. Jong --  Tracy Jong Law Firm Tracy P. Jong -- Tracy Jong Law Firm
For Immediate Release:
Dateline: Rochester , NY
Wednesday, May 22, 2019

 

Complying with Current Good Manufacturing Practices (CGMP) for Dietary Supplements is required for any nutritional supplements that are prepared, packed or stored by a manufacturer or distributor. This is about producing safe products that are consistently manufactured, tested and labeled for sale and the procedure and record-keeping for making that happen. If there is ever a product recall, regulatory agencies need to be able to trace and detect problems so they can be addressed. This is done by reviewing a manufacturer’s production procedures and actual batch production records and samples. Some of the requirements for Complying with Current Good Manufacturing Practices (CGMP)are described below and can be a checklist of things your business needs to do if you are preparing and selling CDB ingestibles or bitters.

  1. For each unique formulation, you need a specification and procedure for its batch production. This is an exact recipe/formula that is used each and every time to ensure consistency batch to batch.
  1. There must be a master manufacturing record with specifications for each point or stage in the manufacturing process where control is necessary to ensure quality of the end product. It needs to be documented that the product was produced in a controlled environment (clean room). Two people should sign off at each step being performed that the step was completed in accordance with written procedures. The written procedures must provide detailed instructions,  precautions to be followed, and what to do to investigate an issue or remediate a problem.
  1. Each component used must have a procedure for identifying it and ensuring its purity, strength and composition. This needs to be tamper-proof. There needs to be minimum standards for quality/contamination that are adequate to ensure the efficacy and quality of the final end product. If you rely on the certificate of analysis coming from the supplier, you need to independently verify it and do periodic random testing to qualify the supplier. (This is generally done by sending it to a testing lab to analyze and send you a report. 3 times are necessary for a supplier that does its own testing to verify and qualify it as reliable. If the supplier does not do its own testing, you will need to test every batch purchased.) If your herbalists can pass test proving they can reliably identify raw herbs accurately by taste/smell/sight, they can substitute for laboratory tests to identify what the component is.) However, that would not suffice for testing its purity and to guaranty the plants did not contain bacteria or heavy metals. Lab tests would be needed for that. You also need a written procedure for being sure a certificate is present with each supply delivery, it is reviewed, and it is stored and recorded in your system for each supply delivery. You also need a written procedure for how each supply is quarantined (not contaminated), stored and labeled at your facility. You need to keep a representative sample of each shipment and record it in your system.
  1. If water is an ingredient or used for filtering, it needs to be tested and records maintained of the water source and how it meets water quality standards.
  1. There must be quality control testing during the manufacturing process for each component. Is it being stored and used under conditions (cleanliness, temperature, light, humidity, etc.) that uphold its integrity and efficacy? How do you ensure it is not being contaminated? For example, you need a written procedure for:
    1. Measuring herbs
    2. Grinding herbs or powders to finer consistency
    3. Blending herbal powders
    4. Mixing herbal liquid blends
    5. Pressing herbs during liquid extraction
  1. There must be specifications for product packaging materials and quality control testing during the packaging process for each component. Are all products, labels and containers being stored and used under conditions (cleanliness, light, temperature, humidity, etc.) that uphold its integrity and ensure the product is not contaminated? How do you ensure it is not being contaminated? How do you ensure how much is being placed in each package? How do you ensure what is being placed in each package? How do you audit and test?
  1. There must be specifications for product packaging and shipping. Are containers damaged? Seals broken? Labels incorrect or missing? Is there the right amount of product in each shipment? Is it being stored and used under conditions (cleanliness, temperature, light, humidity, etc.) that uphold its integrity and ensure the product is not contaminated? How do you ensure what packages are being placed in each shipment? How do you audit and test?
  1. There must be a procedure for validating the packaging and labelling complies with the laws and regulations. How do you do that? Do you have a checklist you use? Do you outsource the review? What records do you retain as proof it was done? How do you control the label access and use? How do you ensure that the right label is used on each batch? Do you ensure each label for each batch is recorded and a sample of the label is retained?
  1. You need an extraction control sheet worksheet for each batch that contains:
    1. Equipment used and processing lines used
    2. Date & time of all maintenance, cleaning and sanitization of the equipment and processing lines or a cross-reference to separate records with this information
    3. Date & time & employee for all testing for in-process quality control or a cross-reference to separate records with this information
    4. Date & time & employee for all testing for final product quality control or a cross-reference to separate records with this information
    5. Date & time & details for all reprocessing or a cross-reference to separate records with this information
    6. Batch numbering (unique identifier for each batch) or a cross-reference to separate records with this information
    7. Sample label used on the batch or a cross-reference to location and separate records with this information
    8. Sample of each batch or a cross-reference to location of such samples
  1. Representative samples must be maintained under good organization and storage conditions. They must be maintained for one year past shelf-life/expiration date or 2 years past distribution of last batch associated with the sample.
  1. You need written quality control procedures and how the testing will be recorded. It also needs to state what happens in the case of a failed inspection. These can include analysis for color, residue, transparency/clarity and other observations to ensure quality).
  1. You need written laboratory procedures that detail the methodology and equipment used, as well as the record keeping of each analysis.
  1. You need written procedures for handling product complaints and how the person reviewing them is qualified.
  1. You need written procedures for calibrating measuring equipment and how the person performing the calibration is trained and qualified. Results must be recorded with date, time and employee.
  1. You need written procedures for inspecting electronic, automatic and mechanical equipment and how the person performing the inspection is trained and qualified. Results must be recorded with date, time and employee.
  1. You need written procedures for cleaning, sanitizing and maintaining equipment, tools, utensils and surfaces and how the person performing the task is trained and qualified. Each time must be recorded with date, time and employee.
  1. You need written procedures for handling product return and what happens to the returned product.
  1. You need written procedures for qualifying and training employees for each task they are assigned to perform.
  1. You need written procedures for documenting and reporting “serious adverse events” to the FDA.
  1. You should have data supporting any expiration dates listed on product packaging.
  1. You need written procedures for handling product recalls.
  1.   You need records to detail where every batch was supplied/distributed and how to contact the buyer in the event of a product recall.

This list is not meant to be exhaustive, but it does include the most important requirements for complying with good manufacturing practices as required by the FDA. Contact our team if you need assistance with regulatory compliance issues for your CBD manufacturing business.

 
attorney
Tracy Jong Law Firm
Rochester, NY
585-247-9170
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