Then, before the sponsor company submits any regulatory filings, it should ensure that the CMO is ready for a preapproval
inspection (PAI) by the regulatory authorities. This is important because any negative observations in the regulatory inspection
may delay product approval.
Preparing for the PAI inspection can be a challenge, especially when the sponsor is using multiple contractors in the product's
supply chain. All contractors will need to be ready for the PAI with robust processes, procedures, training, and agreed contracts.
The companies will need to develop and manage a plan or strategy for effective preparation. This plan can be broken down in
four phases: development of a preapproval inspection plan or policy, implementation of the plan with the contractors, site
preparation, and inspection logistics.8
Responsibility for Lot Release
In the industry, there are differences of opinion about responsibility for lot release practices when dealing with CMOs. Some
companies give complete review and lot release responsibility to the CMO if the certificate of analysis confirms the product
meets all its specifications. Although this approach can decrease release times, because it means product samples and complete
or partial batch records do not have to be sent to the sponsor company's release group, this is not an acceptable practice.
This issue was raised in the FDA Commissioner's 1979 preamble to the GMPs, and is addressed in the Responsibilities of the
Quality Control Unit section, where the commissioner states:
" ... the quality control unit of a contracting firm must approve or reject drug products produced by contractors. The Commissioner
believes this is proper because, in the circumstances described, the contractor does not own the goods, but merely performs
a service for the contracting firm. The responsibility to approve release of a drug product for distribution must rest with
the owner of the drug product."
The Road Ahead
According to a recent survey, CMOs continue to increase their biopharmaceutical manufacturing capacity, and more biotech companies
plan to outsource 10–50% of their capacity in the coming years.10 Similarly, a 2007 outsourcing survey shows that most pharmaceutical companies (61%) plan to spend at least 6% more than
last year on outsourcing.11
As contract manufacturing grows, innovations and the incorporation of technologies will help CMOs and sponsors build trust
and confidence. One example is Cook Pharmica, which was the first CMO to provide live webcam coverage of the manufacturing
process to the sponsor and FDA, with the sponsor's permission.12
Outsourcing is sometimes the only way a company can get a product to market quickly enough and then keep up with market demands.
Partnerships across companies with different disciplines and expertise also help accelerate innovation and introduction of
new products. As pharmaceutical and biopharmaceutical companies continue to strive for low-cost sourcing, speed to market,
and low initial investments, outsourcing will continue to grow.
Giovanni Escobar is a compliance excellence manager in global manufacturing and supply at GlaxoSmithKline, Parsippany, NJ, 973.8892237, firstname.lastname@example.org