Scribd
Upload
25 views4 pages

OOS Results and Quality Control Insights

1. The quality control department evaluates out-of-specification laboratory results to determine if a product failure has occurred and if the product can be released or must be rejected. Product failures include errors caused by operators or issues with the manufacturing process. 2. The department also evaluates the company's retesting procedures and use of resampling to ensure they are following scientific guidelines. A court decision provides limitations on these practices. 3. Averaging test results can hide variability and should generally be avoided, especially for content uniformity and dissolution testing, unless the test protocol specifies otherwise. Blend testing is necessary to detect inferior batches before finished product testing.

Uploaded by

RainMan75
Copyright
© All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as DOCX, PDF, TXT or read online on Scribd
25 views4 pages

OOS Results and Quality Control Insights

1. The quality control department evaluates out-of-specification laboratory results to determine if a product failure has occurred and if the product can be released or must be rejected. Product failures include errors caused by operators or issues with the manufacturing process. 2. The department also evaluates the company's retesting procedures and use of resampling to ensure they are following scientific guidelines. A court decision provides limitations on these practices. 3. Averaging test results can hide variability and should generally be avoided, especially for content uniformity and dissolution testing, unless the test protocol specifies otherwise. Blend testing is necessary to detect inferior batches before finished product testing.

Uploaded by

RainMan75
Copyright
© All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as DOCX, PDF, TXT or read online on Scribd

QUALITY CONTROL ACTIVITY

Activity of Quality Control Department

1. FAILURE (OUT-OF-SPECIFICATION) LABORATORY RESULTS

Evaluate the company’s system to investigate laboratory test failures. These


investigations represent a key issue in deciding whether a product may be
released or rejected and form the basis for retesting, and resampling.

In a recent court decision the judge used the term “out-of-specification”


(OOS) laboratory result rather than the term “product failure” which is more
common to FDA investigators and analysts. He ruled that an OOS result
identified as a laboratory error by a failure investigation or an outlier test.
The court provided explicit limitations on the use of outlier tests and these
are discussed in a later segment of this document., or overcome by retesting.
The court ruled on the use of retesting which is covered in a later segment of
this document. is not a product failure. OOS results fall into three categories:

 laboratory error
 non-process related or operator error

 process related or manufacturing process error

 2. PRODUCT FAILURES


An OOS laboratory result can be overcome (invalidated) when laboratory
error has been documented. 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.

3. RETESTING

Evaluate the company’s retesting SOP for compliance with scientifically


sound and appropriate procedures. 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.

4. RESAMPLING

Firms cannot rely on resampling. 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. to release a product that has failed
testing and retesting unless the failure investigation discloses evidence that
the original sample is not representative or was improperly prepared.
Evaluate each resampling activity for compliance with this guidance.

5. AVERAGING RESULTS OF ANALYSIS

Averaging can be a rational and valid approach when the object under
consideration is total product assay, but as a general rule this practice should
be avoided. The court ruled that the firm must recall a batch that was
released for content uniformity on the basis of averaged test results. because
averages hide the variability among individual 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.

6. BLEND SAMPLING AND TESTING

The laboratory serves a vital function in blend testing which is necessary to


increase the likelihood of detecting inferior batches. Blend uniformity
testing cannot be waived in favor of total reliance on finished product testing
because finished product testing is limited.

You might also like