Table 1 provides an example of analytical testing of a biopharmaceutical product.3,4 Identity, strength, purity, and potency assays should be qualified or validated. Accuracy, precision, specificity, and reproducibility
of test methods should be established during validation. Technical transfer of the analytical methods should be performed
with a qualified laboratory. Test article characterization for each batch or stability condition has to be documented. The
analytical raw data and the reported results should be verified for data accuracy and integrity. Any deficiencies or deviations
must be reported.
Table 1. Laboratory Testing Required for a Biopharmaceutical Product
Current and approved analytical methods should be used for testing of samples. A copy of the draft method should be part of
the ancillary documentation until the official method is published. System suitability results and acceptance criteria for
the assay, per method, should be documented in the laboratory notebook.
Reference material should be fully characterized and documented, properly stored, secured, and utilized during testing.4 Identity tests for products are usually confirmed by comparison with the appropriate reference standard (Table 1). Reference
standards should therefore be periodically evaluated for meeting appropriate specifications. Laboratory cultures and labile
reagents have to be stored under suitable storage conditions.4
CGMPs require an adequate number of qualified personnel with practical experience to perform the assigned tasks.4 Training in cGMP practice is provided by a qualified trainer and periodically assessed. An active cGMP training program
should be current and ensure that personnel are adequately trained and perform the functions they are responsible for, follow
procedures for necessary precautions, and review laboratory data. Summaries of training and position description should be
verified, maintained, and current. Ideally, the training department provides general training (e.g., weighing, pH), and specific
laboratories provide functional training (e.g., HPLC, ELISA).
A deviation is an event in which procedures are not or cannot be followed. Investigations, which should attempt to identify
the root cause, involve initial observations, immediate action, and corrections to ensure that the problem does not recur.
Final disposition of any affected products should also take place. The formal report generated includes corrective actions
taken on deficiencies previously exposed by audits. Subsequent inspections should guarantee that all corrections have been
implemented in a timely manner.
Current GMP expectations include what the regulatory agencies consider feasible and viable. "Best of industry" practices extend
beyond written regulations. The percentage of time a laboratory scientist must allocate for common GMP activities is estimated
in Figure 2. Time is allocated equally for both testing as well as compliance activities. It is critical for everyone to stay
abreast of current cGMP requirements and guidelines. Implementing the cGMP regulations and guidelines enables the industry
to prevent, detect, analyze, and correct problems and failings, ensuring that drug products are consistently high quality.
Figure 2. The estimated percentage of time required for common cGMP activities in the laboratory
In the past, regulations were created as a reaction to problems and inspections were based on a checklist. Today's regulators
encourage a proactive approach. Strategies include implementing and integrating quality systems substantiated on new technological
advances and risk-based approaches. The FDA5 describes risk-based approach as one
"designed to establish product quality . . . founded on sound science and engineering principles for assessing and mitigating
risks of poor product and process quality in the context of the intended use of pharmaceutical products."