PHARMACEUTICAL PACKAGING: Beyond Equipment
Terry Petro
December 2001 A2C2 --

Software speeds and simplifies time-consuming, essential tasks.

Three-quarters of the customers purchasing one manufacturer’s pharmaceuticalpackaging equipment now also purchase optional software that provides documentation for qualification and validation. These packages offer increasing levels of documentation and service on equipment specifications and performance to those specifications, up to and including running the qualification testing at the user’s site. 

At all levels, process documentation helps ease the strain of preparing the support materials for a company’s filing for FDAapproval of a new pharmaceutical products.  A subset of filing is documenting that the processing equipment has been tested to assure it is performing reliably according to its specifications. Ultimately the pharmaceutical manufacturer is responsible for supplying the data to support that validation, but documentation generated by the equipment manufacturer can play a valuable part in the process. Pharmaceutical companies choose the software approach for varied reasons: whether small or large, they often cannot spare the experienced staff members capable of doing the work for the length of time such procedures require. Writing the test protocols, then performing the tests, may imply a lack of objectivity that requires time and effort to overcome—time and effort that may delay the launch of a critical new product. Like hiring a third-party evaluator, having the equipment’s performance verified by the equipment's manufacturer may imply greater credibility.

Not every call for documentation involves FDA approval. Customers purchasing cartoners or other secondary equipment also purchase documentation software to ensure that the equipment is running to cGMP standards and to set a baseline for performance measurement.  As documentation capabilities have evolved over the past ten years, software services have been divided into packages so that users can select the level of assistance they need.  

Standard documentation packages should include the following:

  • Operator’s manual setting forth operational and maintenance procedures

  • Service manual containing assembly drawings, electrical and control schematics .PLC programs on disk

  • Bill of materials

  • Certificates ensuring that approved materials, finish, and welds have been used in manufacturing parts that contact the product

  Optional packages should include:

  • Functional machine description

  • Control tests that verify all functions, alarms, and controls on the equipment. Each is checked and one page of documentation is supplied. Most machines have 200-300 individual tests; larger equipment may have as many as 400.

  • Instrument list verifying that all process-critical devices are present and that the equipment is built as designed. List also supplies part numbers and serial numbers. During factory acceptance testing, all set points, ranges, and limits are recorded. .Required equipment specifications including all contractual documents, customer specifications, and change orders. This option defines the scope of the equipment.

And may include...

Additional services offered by equipment manufacturers may include writing the IQ/OQ/PQ protocols for equipment qualification testing. Such a service can save the end user or its third-party testing firm the costly time and effort required for writing test protocols for equipment. The test results are also more complete and tend to produce more accurate documentation when the protocol is written by the machine manufacturer familiar with the equipment. The manufacturer may also be able to supply operating personnel to run the equipment during testing and/or providing supervision of staff or third party firm personnel to ensure thoroughness. In some cases, manufacturer can even perform the protocol testing for the user. 

Clearly, the main benefit of having a manufacturer involved in providing documentation, writing protocols, and assisting in the testing process is saved time and reduced cost of qualifying equipment. But a high level of accurate detail in equipment and test documentation is also a valuable investment that may be useful during FDA inspections. 

Documentation services have evolved into an integral part of customer service in the pharmaceutical and nutraceutical applications. It is expected that the value will continue to grow as equipment increased in complexity as electronic sensors, alarms, and controls enter the marketplace.  Copyright © 2010 Vicon Publishing, Inc.