Quality Control of Pharmaceuticals: Compendial Standards and Specifications. Book · April with 10, Reads. Publisher. download The Quality Control of Medicines - 1st Edition. Print Book & E-Book. ISBN , Proceedings of the 35th International Congress of Pharmaceutical Sciences, Dublin, 0 star rating Write a review. The pharmaceutical quality control handbook. Front Cover. Rhys Bryant. Aster Pub. From inside the book 3. Quality Control in New Drug Development.
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Pharmaceutical Quality Control Lab Guidebook: GMP (Good Manufacturing Practices) For Used condition books; It shows signs of wear from consistent use. Pharmaceutical Quality Control Handbook [Rhys Bryant] on chancromaslodis.cf Story time just got better with Prime Book Box, a subscription that delivers editorially. This book is a valuable reference .The book contains everything you need to ensure full compliance and superior quality control.
This book and its accompanying CD-ROM comprise detailed text, summaries, test papers, and answers to test papers, providing an administrative solution for management. Each company must create a definite training matrix of its employees.
The training procedures in this book enable end users to understand the principles and elements of manufacturing techniques and provide documentation language ranging from the generic to the specific. Syed Imtiaz Haider, Ph. We provide complimentary e-inspection copies of primary textbooks to instructors considering our books for course adoption. CPD consists of any educational activity which helps to maintain and develop knowledge, problem-solving, and technical skills with the aim to provide better health care through higher standards.
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Toggle navigation Additional Book Information. Description Table of Contents Author s Bio. Specifications and analytical procedures should be suitable and, as applicable, in conformance with application commitments and compendial requirements. Evaluate raw laboratory data, laboratory procedures and methods, laboratory equipment,including maintenance and calibration, and methods validation data to determine the overall quality of the laboratory operation and the ability to comply with CGMP regulations.
Examine chromatograms and spectra for evidence of impurities, poor technique, or lack of instrument calibration.
Most manufacturers use systems that provide for the investigation of laboratory test failures.
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These are generally recorded in some type of log. Ask to see results of analyses for lots of product that have failed to meet specifications and review the analysis of lots that have been retested, rejected, or reworked.
Evaluate the decision to release lots of product when the laboratory results indicate that the lot failed to meet specifications and determine who released them. Pre-Approval Documents relating to the formulation of the product, synthesis of the bulk drug substance, product specifications, analysis of the product, and others are examined during the review process in headquarters.
However, these reviews and evaluations depend on accurate and authentic data that truly represents the product. Pre-approval inspections are designed to determine if the data submitted in an application are authentic and accurate and if the procedures listed in the application were actually used to produce the data contained in the application. Additionally, they are designed to confirm that plants including the quality control laboratory are in compliance with CGMP regulations.
The analytical sections of drug applications usually contain only test results and the methods used to obtain them. Sponsors are not required to file all the test data because such action would require voluminous submissions and would often result in filing redundant information.
Sponsors may deliberately or unintentionally select and report data showing that a drug is safe and effective and deserves to be approved. The inspection team must decide if there is valid and scientific justification for the failure to report data which demonstrates the product failed to meet its predetermined specifications.
The pharmaceutical quality control handbook
Coordination between headquarters and the field is essential for a complete review of the application and the plant. Experienced investigators and analysts may contact the review chemist with appropriate supervisory concurrence when questions concerning specifications and standards arise. Inspections should compare the results of analyses submitted with results of analysis of other batches that may have been produced.
Evaluate the methods and note any exceptions to the procedures or equipment actually used from those listed in the application and confirm that it is the same method listed in the application. The analyst is expected to evaluate raw laboratory data for tests performed on the test batches biobatches and clinical batches and to compare this raw data to the data filed in the application. 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. The court ruled on the use of retesting which is covered in a later segment of this document. OOS results fall into three categories: - laboratory error - non-process related or operator error - process related or manufacturing process error A.
Laboratory errors must be determined through a failure investigation to identify the cause of the OOS. Once the nature of the OOS result has been identified it can be classified into one of the three categories above.
The inquiry may vary with the object under investigation. Nevertheless, a laboratory investigation consists of more than a retest. The inability to identify an error's cause with confidence affects retesting procedures, not the investigation inquiry required for the initial OOS result. 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. 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.
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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. 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. If there is a computer data base, determine the protocols for making changes to the data. There should be an audit trail for changes to data. We expect raw laboratory data to be maintained in bound, not loose or scrap sheets of paper , books or on analytical sheets for which there is accountability, such as prenumbered sheets.
For most of those manufacturers which had duplicate sets of records or "raw data", non-numbered loose sheets of paper were employed.
Some companies use discs or tapes as raw data and for the storage of data.
Such systems have also been accepted provided they have been defined with raw data identified and validated. Carefully examine and evaluate laboratory logs, worksheets and other records containing the raw data such as weighings, dilutions, the condition of instruments, and calculations.
Note whether raw data are missing, if records have been rewritten, or if correction fluid has been used to conceal errors.Also, evaluate the methods used to test and establish bioburdens.
The analyst is expected to evaluate raw laboratory data for tests performed on the test batches biobatches and clinical batches and to compare this raw data to the data filed in the application.
The inspection team is expected to review such letters on file at the district office, and they are expected to ask the plant for access to such letters. Access online or offline, on mobile or desktop devices Bookmarks, highlights and notes sync across all your devices Smart study tools such as note sharing and subscription, review mode, and Microsoft OneNote integration Search and navigate content across your entire Bookshelf library Interactive notebook and read-aloud functionality Look up additional information online by highlighting a word or phrase.
Evaluate the methods and note any exceptions to the procedures or equipment actually used from those listed in the application and confirm that it is the same method listed in the application.
U.S. Food and Drug Administration
Be the first to review this item site Bestsellers Rank: RS calibration plays an important role in various aspects of quality assurance in pharmaceutical industry , such as good manufacturing practice, product releases as well as commercial implications. 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.
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