Biopharmaceutical companies often look to specialized contract service companies to help them meet regulations, before and
after market approval, and to maximize their resources. But they may be overlooking the expertise of their process equipment
Aside from equipment, some suppliers also provide consulting services for equipment documentation, process validation, automation,
The September 2003 draft guidance "Sterile Drug Products Produced by Aseptic Processing" recommends that drug manufacturers
validate their sterilizing filtration processes specific to each drug, but it also acknowledges that suitable testing is probably
beyond the capabilities of most drug manufacturers. This work can be outsourced, and FDA has recognized that some filter suppliers
are experts in validation.
It is an established practice for qualified filter suppliers to conduct drug product-specific bacteria or mycoplasma retention
testing; related tests for filter compatibility, extractables, and integrity test values; and to provide "FDA-ready" documentation
substantiating that the selected filters can sterilize the drug product.
With the emergence of new technologies, suppliers are providing even more extensive validation documentation and services.
For example, to make sterile pathways, drug manufacturers historically have relied on manual tubing connections; this approach
requires specialized capital equipment — laminar flow HEPA filtered hoods and tubing welders, for example — and highly trained
operators. With the introduction of new aseptic connection devices, sterile pathways can be created on the open production
floor without extensive training. These devices can provide a higher level of sterility assurance, they are free of capital
costs, and they allow aseptic connections to be more easily performed.
The question for any new technology is how to validate it. Suppliers can apply the worst-case uses of their products and conduct,
in advance, all the applicable validation work at their own facilities. Thereafter, the supplier's product is launched with
much of the user's validation work already documented.
This greater degree of supplier testing and documentation is a significant advance. Today, suppliers are helping users meet
21 CFR Part 11 regulations for electronic records. The "Good Automated Manufacturing Practice Guide for Validation of Automated
Systems" was developed by an industry forum and establishes how suppliers' design and development documentation can eliminate
users' need to generate their own. Beyond easing the drug manufacturers' documentation and validation learning curve, this
practice is also more cost effective. The supplier does it once and costs can be spread broadly among its many customers.
Suppliers are also expanding their consulting services, such as troubleshooting and pre-inspection reviews of equipment usage.
One supplier provides experts who visit a plant to review equipment usage, record observations, and provide recommendations
to the client. This is a cost-effective means to reduce adverse FDA observations and retrieve information which can, in the
event of a compliance issue, help scientifically justify a manufacturing practice.
With the pharmaceutical industry becoming increasingly globalized, major suppliers must prepare themselves to support customers
everywhere. They must monitor regulatory practices in Canada, Europe, Australia, Japan, and elsewhere. Although equipment
usage, validation, and compliance requirements tend to have commonalities worldwide, local support is necessary to ensure
sensitivity to national regulations or regional practices and to allow the supplier to provide an approach that is applicable
Major equipment suppliers can play an important role in helping pharmaceutical manufacturers meet diverse requirements. Many
are experts in the technology they offer, including its use. Ultimately, that expertise is what regulators want drug manufacturers
to have. Obtaining that knowledge from suppliers is faster, easier, and more cost effective than when users try to develop
it internally. Global suppliers are focusing on expanding their offerings by providing related services. The pharmaceutical
industry will benefit by viewing their equipment suppliers as experts in the validation and compliant use of their equipment
— not simply as vendors. BPI