Where necessary, I have provided my comments after each excerpt. In some specific cases, the words of the Guidance are highlighted and underlined, followed immediately after by my related comments. This represents a less than full schedule of testing and should therefore be justified and presented to and approved by the regulatory authority prior to implementation. Author Comment: In a GMP-controlled process, the burden of testing every lot is time-consuming and expensive. Perhaps this may be addressed in later attachments.
|Genre:||Health and Food|
|Published (Last):||14 October 2017|
|PDF File Size:||6.12 Mb|
|ePub File Size:||13.36 Mb|
|Price:||Free* [*Free Regsitration Required]|
You can change your ad preferences anytime. Q6 guidelines. Upcoming SlideShare. Like this presentation? Why not share! Embed Size px. Start on. Show related SlideShares at end. WordPress Shortcode. Published in: Education. Full Name Comment goes here. Are you sure you want to Yes No. Jayarami Reddy. Sumana Tharigopula. Show More.
No Downloads. Views Total views. Actions Shares. Embeds 0 No embeds. No notes for slide. Q6 guidelines 1. Objective of the Guideline This guideline is intended to assist to the extent possible, in the establishment of a single set of global specifications for new drug substances and new drug products. It provides guidance on the setting and justification of acceptance criteria and the selection of test procedures for new drug substances.
Periodic or Skip Testing 2. Release vs. Shelf-life Acceptance Criteria 3. In-process Tests 4. Design and Development Considerations 5. Limited Data Available at Filing 6. Parametric Release 7. Alternative Procedures 8. Pharmacopoeial Tests and Acceptance Criteria 9. Evolving Technologies Reference Standard 5.
This concept may be applicable to, for example, residual solvents and microbiological testing, for solid oral dosage forms. Shelf-life Acceptance Criteria The concept of different acceptance criteria for release vs. Examples where this may be applicable include assay and impurity degradation product levels. In-process Tests In-process tests which are only used for the purpose of adjusting process parameters within an operating range, e.
Design and Development Considerations The experience and data accumulated during the development of a new drug substance or product should form the basis for the setting of specifications. It may be possible to propose excluding or replacing certain tests on this basis. Some examples are: microbiological testing for drug substances and solid dosage forms ,particle size testing 7.
Limited Data Available at Filing It is recognized that only a limited amount of data may be available at the time of filing, which can influence the process of setting acceptance criteria. When only limited data are available, the initially approved tests and acceptance criteria should be reviewed as more information is collected, with a view towards possible modification. This could involve loosening, as well as tightening, acceptance criteria as appropriate. Parametric Release Parametric release can be used as an operational alternative to routine release testing for the drug product in certain cases when approved by the regulatory authority.
Sterility testing for terminally sterilized drug products is one example. Alternative Procedures Alternative procedures are those which may be used to measure an attribute when such procedures control the quality of the drug substance or drug product to an extent that is comparable or superior to the official procedure.
Example: for tablets that have been shown not to degrade during manufacture, it may be permissible to use a spectrophotometric procedure for release as opposed to the official procedure, which is chromatographic. Pharmacopoeial Tests and Acceptance Criteria References to certain procedures are found in pharmacopoeias in each region. Impact of Drug Substance on Drug Product Specifications In general, it should not be necessary to test the drug product for quality attributes uniquely associated with the drug substance.
Example: it is normally not considered necessary to test the drug product for synthesis impurities which are controlled in the drug substance and are not degradation products. Reference Standard A reference standard, or reference material, is a substance prepared for use as the standard in an assay, identification, or purity test.
It should have a quality appropriate to its use. Specifications: Definition and Justification 1. It establishes the set of criteria to which a new drug substance or new drug product should conform to be considered acceptable for its intended use.
The justification should refer to relevant development data, pharmacopoeial standards, test data for drug substances and drug products used in toxicology and clinical studies, and results from accelerated and long term stability studies, as appropriate. This justification may consider theoretical tolerances for a given procedure or acceptance criterion, but the actual results obtained should form the primary basis for whatever approach is taken. Presentation of test results in graphic format may be helpful in justifying individual acceptance criteria, particularly for assay values and impurity levels.
Differences in these forms could, in some cases, affect the quality or performance of the new drug products. Physicochemical measurements and techniques are commonly used to determine whether multiple forms exist.
Impurities 2. Assay 3. Degradation products 2. Identity e Water content: This test is important in cases where the new drug substance is known to be hygroscopic or degraded by moisture.
These should be suitably determined using pharmacopoeial procedures. One or more of these tests may also be applicable to soft capsules and granules. Objective This guidance document provides general principles on the setting and justification, to the extent possible, of a uniform set of international specifications for biotechnological and biological products to support new marketing applications.
Characterization a Physicochemical properties b Biological activity Analytical Considerations 2. Process Controls 3. Performing such testing may eliminate the need for testing of the drug substance or drug product.
Pharmacopoeial Specifications 3. Release Limits vs. Shelf-life Limits This concept pertains to the establishment of limits which are tighter for the release than for the shelf-life of the drug substance or drug product.
Examples where this may be applicable include potency and degradation products. Statistical Concepts Appropriate statistical analysis should be applied, when necessary, to quantitative data reported. You just clipped your first slide! Clipping is a handy way to collect important slides you want to go back to later. Now customize the name of a clipboard to store your clips. Visibility Others can see my Clipboard.
Establishing Patient Centric Specifications for Drug Substance and Drug Product Impurities
Putting Q6A to the Test: Upon Dissection, Guidance Needs an Update