Googling the term “technical services” returns a host of responses from military contractor companies to various library references. In discussion with many of our pharmaceutical clients, it is obvious that most major companies host technical service divisions, but the functions vary widely from computer related services to some part of manufacturing or engineering. While somewhat self-serving to the work performed at Whitehouse Laboratories, the purpose of this article is to answer a question we are asked almost daily – what testing does your technical services division perform? The short answer is very simple. Whitehouse Lab’s Technical Services performs a host of tests that do not routinely fit into the container, package or material testing business units. The longer or more accurate answer is outlined in the remaining parts of this article.
The five common and key service areas are as follows:
These products are typically a mixture of active drug components and excipients, along with other non-reusable material or packaging. Depending on the method or route for administration, dosage forms are classified as liquids or solids. Regulatory requirements stress the importance of testing these dosing units to ensure that the proper delivery of the finished product is made regardless of who or what is administering it. In conjunction with the proper delivery of the finished product, companies need to verify that the dosages being administered are accurate to the labeled dosage amount. Relevant Standards that address Unit Dose and Dose Accuracy:
- ISO 11608: Needle-based Injections for Medical Use
- USP <698> Deliverable Volume
- USP <755> Minimum Fill
- USP <905> Uniformity of Dosage Units
Regulatory agencies require that designs for devices, containers and packaging meet specific expectations prior to marketing a finished product. Mechanical testing provides data in which the suitability and functionality of the materials being utilized for the intended application are evaluated under specific conditions, such as temperature, tension, compression, and load. In addition, materials or components may be evaluated to determine whether their physical properties and functionality are manufactured to the specifications as designed by package engineers. Common test methods and procedures that are classified as a form mechanical testing include:
- Tensile ASTM and ISO 527
- Physical Properties
Stability studies provide imperative data essential for assessing how the quality of a product varies over time under specific environmental factors, such as temperature, humidity, and light. Stability testing helps to establish recommended storage conditions, retest periods, and shelf-life for a finished product. Regulatory agencies require that cGMP ICH stability and storage programs be performed as part of the clinical trial process to support NDA and aNDA submissions and to define a program for the management of retain samples.
CLEANING VALIDATIONS (Swabbing, Analysis)
As part of the good manufacturing practice guidelines, it is imperative that validation of the cleaning process is conducted to ensure that cross-contamination, contamination, and residuals are removed. FDA requires that Cleaning Validations be performed for changes in procedure, equipment, formulations, and cleaning procedures, as they have a direct impact on the finished product. Dependent on the product, sampling techniques can include rinsing, swabbing, or other specific practices. The method validation process will address critical attributes such as precision, linearity, recovery, LOD, and LOQ. In addition to developing analytical methods, non-specific methods such as Total Organic Carbon (TOC) can be utilized for detection of all carbon-containing compounds that are soluble in water. TOC results can not specifically identify the residual compound, but the sensitivity allows results to be obtained in the ppb range. Routine cleaning validation methods include Compound Specific types and Total Organic Carbon. Both methods may be used in routine analysis of cleaning validation samples.
An important step in the development of a new product or device is the evaluation of Extractables and Leachables. Compounds can leach into drug products through components used in the manufacturing equipment, devices, or packaging. These studies are required to adhere to the safety standards for marketed products. Using GC/MS, HPLC, GC and ICP methodology potential extractables can be identified.
In summary, this article aims to provide a more defined overview of technical services from the viewpoint of a contract laboratory. However, the article would be remiss if it did not reiterate that the following also applies: The Whitehouse Lab’s Technical Service Team has a broad and expansive experience base that extends outside the boundaries of the five key areas outlined above. If during your testing and qualification development process you come across unique requirements, do not hesitate to take a moment to “Google” your need. In most cases, someone out there in the vast world of the Internet may be able to help.