Certain requirements of the FDA Good Manufacturing Practices (GMP) apply to us as a Quality Control Laboratory.

FDA cGMP Compliance

Some apply generally to normal, everyday operations like personnel training, calibration, and maintenance. But several sections require that we have specific knowledge of drug product or raw material specifications, and the need for GMP compliance.

Without this information, no lab can comply with the regulations. The following is just a reminder of what information you need to supply in order for us to comply with GMP. For example, we need to know the correct name and specifications of the product. Without the correct name, we may not be able to run the proper tests. Without the specifications we cannot institute the proper procedures for out of specification results.

Validated Methods

In many testing situations (data for R&D or information only), validated methods are not required. But GMP requires the use of validated or compendial methods. Not all methods have been site validated. And even if they have been validated for some products, they may not be validated for your product. When you need to comply with GMP, ask for validated methods. Typical costs for partially validating a method for a single laboratory are from $2000 to $5000. If you have already validated the method, we need to have a copy of the SOP and the validation report. Then we need to either repeat parts of the validation protocol or at least meet suitability criteria. 

Raw Data and Record Retention

Another crucial part of GMP compliance is records and raw data retention.  Normally we store raw data for five years. Records for GMP compliance must be stored longer depending on the expiration and distribution of the product. This may be for more than ten years. We think the best policy for the client is that the client stores the raw data as long as necessary. Copies of chromatograms are normally provided with the summary report for pharmaceutical clients.  QA audited data packages are available, upon request, at an additional charge. We recently adopted a standard format for GLP/GMP Data Packages with the information below.

GMP Data Package

1. Table of Contents - all pages numbered
2. Introduction - a general description of the analytical approach or study
3. Study Information - identification of all study personnel, dates, and disposition of data and test articles.
4. Procedures - further details on the study procedures, SOPs, results, etc.
5. Quality Assurance Statement - details of QC parameters and impact on data quality, compliance statement
6. Signatures of all study personnel
7. Raw Data - copies of logbooks, sample prep notes, chromatograms, calculations, etc.

In conclusion, if you need GMP compliance, we need at least the above information before analysis begins. Also plan to store the raw data; it's in your best interests.