1. Pharmaceutical Toxicology in Practice | Wiley Online Books
  2. Pharma Guide
  3. Pharmaceutical Books
  4. U.S. Food and Drug Administration

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Unfortunately, in most textbooks the mathematical descriptions necessary to develop a deeper understanding of kinetic models are omitted. As a result many chemists and biologists veer rapidly away from thermodynamics and kinetics.

Pharmaceutical Toxicology in Practice | Wiley Online Books

For some scientists, this can lead to confusion on how to apply these models to real-life situations. For example, many enzyme kinetic models are formulated as rate equations. Since experimentally measurements typically determine concentrations and rarely determines rates directly, confusion arises on how to apply kinetic models.

In this case, either the model is integrated to give a description of the concentration course of the enzyme reaction or the data is differentiated i. The level of mathematical skills required to solve kinetic models is minimal for anyone who has studied college level algebra and calculus.

Thus, the objective of this book is to present a brief review of thermodynamics and kinetics followed by a detailed step-by-step approach in developing and solving kinetic models for complex chemical and biological processes. The firm's analyst should follow a written procedure, checking off each step as it is completed during the analytical procedure. We expect laboratory test data to be recorded directly in notebooks; use of scrap paper and loose paper must be avoided.

These common sense measures enhance the accuracy and integrity of data. Review and evaluate the laboratory SOP for product failure investigations. Specific procedures must be followed when single and multiple OOS results are investigated. For the single OOS result the investigation should include the following steps and these inquiries must be conducted before there is a retest of the sample: - the analyst conducting the test should report the OOS result to the supervisor - the analyst and the supervisor should conduct an informal laboratory investigation which addresses the following areas: 1.

However, specific restrictions must be placed on the use of this test. Firms cannot frequently reject results on this basis. The USP standards govern its use in specific cases only.

The test cannot be used for chemical testing results. An initial content uniformity test was OOS followed by a passing retest. The initial OOS result was claimed the result of analyst error based on a statistical evaluation of the data.

The court ruled that the use of an outlier test is inappropriate in this case..

It is never appropriate to utilize outlier tests for a statistically based test, i. Determine if the firm uses an outlier test and evaluate the SOP. Determine that a full scale inquiry has been made for multiple OOS results. This inquiry involves quality control and quality assurance personnel in addition to laboratory workers to identify exact process or non process related errors.

When the laboratory investigation is inconclusive reason for the error is not identified the firm: 1. Cannot conduct 2 retests and base release on average of three tests 2. Cannot use outlier test in chemical tests 3. Cannot use a re-sample to assume a sampling or preparation error 4. Can conduct a retest of different tablets from the same sample when a retest is considered appropriate see criteria elsewhere C.

The company must: 1. State the reason for the investigation 2. Provide summation of the process sequences that may have caused the problem 3. Outline corrective actions necessary to save the batch and prevent similar recurrence 4.

List other batches and products possibly affected, the results of investigation of these batches and products, and any corrective action. Specifically: - examine other batches of product made by the errant employee or machine - examine other products produced by the errant process or operation 5. Preserve the comments and signatures of all production and quality control personnel who conducted the investigation and approved any reprocessed material after additional testing D.

Investigations along with conclusions reached must be preserved with written documentation that enumerates each step of the investigation. The evaluation, conclusion and corrective action, if any, should be preserved in an investigation or failure report and placed into a central file. However, non-process and process related errors resulting from operators making mistakes, equipment other than laboratory equipment malfunctions, or a manufacturing process that is fundamentally deficient, such as an improper mixing time, represent product failures.


Examine the results of investigations using the guidance in section 5 above and evaluate the decision to release, retest, or rework products. A very important ruling in one recent court decision sets forth a procedure to govern the retesting program. This district court ruling provides an excellent guide to use in evaluating some aspects of a pharmaceutical laboratory, but should not be considered as law, regulation or binding legal precedent.

The court ruled that a firm should have a predetermined testing procedure and it should consider a point at which testing ends and the product is evaluated. If results are not satisfactory, the product is rejected. Additionally, the company should consider all retest results in the context of the overall record of the product.

This includes the history of the product. The court ordered a recall of one batch of product on the basis of an initial content uniformity failure and no basis to invalidate the test result and on a history of content uniformity problems with the product.

Pharma Guide

Failing assay results cannot be disregarded simply on the basis of acceptable content uniformity results. The number of retests performed before a firm concludes that an unexplained OOS result is invalid or that a product is unacceptable is a matter of scientific judgment.

The goal of retesting is to isolate OOS results but retesting cannot continue ad infinitum. In the case of nonprocess and process-related errors, retesting is suspect. Because the initial tests are genuine, in these circumstances, additional testing alone cannot contribute to product quality.

The court acknowledged that some retesting may precede a finding of nonprocess or process-based errors. Once this determination is made, however, additional retesting for purposes of testing a product into compliance is not acceptable. For example, in the case of content uniformity testing designed to detect variability in the blend or tablets, failing and non-failing results are not inherently inconsistent and passing results on limited retesting do not rule out the possibility that the batch is not uniform.

As part of the investigation firms should consider the record of previous batches, since similar or related failures on different batches would be a cause of concern. Retesting following an OOS result is ruled appropriate only after the failure investigation is underway and the failure investigation determines in part whether retesting is appropriate.

It is appropriate when analyst error is documented or the review of analyst's work is "inconclusive" , but it is not appropriate for known and undisputed non-process or process related errors. The court ruled that retesting: - must be done on the same, not a different sample - may be done on a second aliquot from the same portion of the sample that was the source of the first aliquot - may be done on a portion of the same larger sample previously collected for laboratory purposes 8.

The court ordered the recall of one batch of product after having concluded that a successful resample result alone cannot invalidate an initial OOS result.

Evaluate each resampling activity for compliance with this guidance. The court ruled that the firm must recall a batch that was released for content uniformity on the basis of averaged test results. This phenomenon is particularly troubling if testing generates both OOS and passing individual results which when averaged are within specification. Here, relying on the average figure without examining and explaining the individual OOS results is highly misleading and unacceptable.

Content uniformity and dissolution results never should be averaged to obtain a passing value. In the case of microbiological turbidimetric and plate assays an average is preferred by the USP. In this case, it is good practice to include OOS results in the average unless an outlier test microbiological assays suggests the OOS is an anomaly.

Blend uniformity testing cannot be waived in favor of total reliance on finished product testing because finished product testing is limited. One court has ruled that sample size influences ultimate blend test results and that the sample size should resemble the dosage size.

Pharmaceutical Books

Any other practice would blur differences in portions of the blend and defeat the object of the test. If a sample larger than the unit must be taken initially, aliquots which resemble the dosage size should be carefully removed for the test, retests, and reserve samples. Obviously, the initial larger sample should not be subjected to any additional mixing or manipulation prior to removing test aliquots as this may obscure non-homogeneity. Multiple individual blend uniformity samples taken from different areas cannot be composited.

However when variation testing is not the object of assay testing, compositing is permitted. If firms sample product from sites other than the blender, they must demonstrate through validation that their sampling technique is representative of all portions and concentrations of the blend. This means that the samples must be representative of those sites that might be problems; e.

Data that should be reviewed include preservative effectiveness testing, bioburden data, and product specific microbiological testing and methods.

For drug substance labs evaluate methods validation and raw data for sterility, endotoxin testing, environmental monitoring, and filter and filtration validation. Also, evaluate the methods used to test and establish bioburdens. Refer to the Microbiological Inspection Guide for additional information concerning the inspection of microbiological laboratories. Follow the sampling guidelines in CP Be prepared to examine all records and worksheets for accuracy and authenticity and to verify that raw data are retained to support the conclusions found in laboratory results.

Review laboratory logs for the sequence of analysis versus the sequence of manufacturing dates. Test dates should correspond to the dates when the sample should have been in the laboratory.

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