Those who have already submitted their comments are welcome to revise their contribution if they would like to. Only their latest comments will be considered. Annex 1 was first published in , to ensure sterility of medicinal products placed on the market for the benefits of patients. Since then it has undergone a number of targeted updates but, until now it has not undergone a full review.
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Published on Feb 3, SlideShare Explore Search You. Submit Search. Successfully reported this slideshow. We use your LinkedIn profile and activity data to personalize ads and to show you more relevant ads. You can change your ad preferences anytime. Ich Q7A Guidelines. Upcoming SlideShare. Like this presentation? Why not share! Embed Size px. Start on. Show related SlideShares at end. WordPress Shortcode. Full Name Comment goes here. Are you sure you want to Yes No. Priscilla Mason As a single mother every little bit counts!
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It is also intended to help ensure that APIs meet the requirements for quality and purity that they purport or are represented to possess. It applies to the manufacture of sterile APIs only up to the point immediately prior to the APIs being rendered sterile. The sterilization and aseptic processing of sterile APIs are not covered by this guidance, but should be performed in accordance with GMP guidelines for drug medicinal products as defined by local authorities. Scope 4. API Starting Materials normally have defined chemical properties and structure.
Quality management Principles Responsibility of all persons -Establish, document, and implement an effective system for managing quality that involves the active participation of management and appropriate manufacturing personnel -There should be a quality unit s that is independent of production and that fulfills both quality assurance QA and quality control QC responsibilities.
Releasing or rejecting all APIs. These responsibilities should be described in writing and should include but not necessarily be limited to: 9. Performing product quality reviews Responsibility for Production Activities 1. The responsibility for production activities should be described in writing, and should include but not necessarily be limited to: 2. Producing APIs and, when appropriate, intermediates according to pre-approved instructions; 3.
Reviewing all production batch records and ensuring that these are completed and signed; 4. Making sure that all production deviations are reported and evaluated and that critical deviations are investigated and the conclusions are recorded; 5. Making sure that production facilities are clean and when appropriate disinfected; 6.
Making sure that the necessary calibrations are performed and records kept; 7. Making sure that the premises and equipment are maintained and records kept; 8. Making sure that validation protocols and reports are reviewed and approved; 9. Evaluating proposed changes in product, process or equipment; and Making sure that new and, when appropriate, modified facilities and equipment are qualified Internal Audits Self Inspection Product Quality Review Regular quality reviews of APIs should be conducted with the objective of verifying the consistency of the process.
Such reviews should normally be conducted and documented annually and should include at least Personnel Hygiene Lighting Adequate lighting should be provided in all areas to facilitate cleaning, maintenance, and proper operations. Equipment Maintenance and Cleaning Written procedures should be established for cleaning of equipment and its subsequent release for use in the manufacture of intermediates and APIs These procedures should include: For APIs with retest dates, records should be retained for at least 3 years after the batch is completely distributed If electronic signatures are used on documents, they should be authenticated and secure Batch Production Records Prepared for each intermediate and API Batch or identification number should include complete information relating to the production and control of each batch.
The batch production record should be checked before issuance to assure that it is the correct version and a legible accurate reproduction of the appropriate master production instruction.
These records should be numbered with a unique batch or identification number, dated and signed when issued. In continuous production, the product code together with the date and time can serve as the unique identifier until the final number is allocated Material management Receipt and Quarantine Samples should be representative of the batch Storage Materials should be handled and stored in a manner to prevent degradation, contamination, and cross-contamination.
Materials stored in fiber drums, bags, or boxes should be stored off the floor and, when appropriate, suitably spaced to permit cleaning and inspection.
Materials should be stored under conditions and for a period that have no adverse affect on their quality, and should normally be controlled so that the oldest stock is used first Rejected materials should be identified and controlled under a quarantine system designed to prevent their unauthorised use in manufacturing.
Contamination Control Residual materials can be carried over into successive batches of the same intermediate or API if there is adequate control Examples include residue adhering to the wall of a micronizer, residual layer of damp crystals remaining in a centrifuge bowl after discharge, and incomplete discharge of fluids or crystals from a processing vessel upon transfer of the material to the next step in the process.
Such carryover should not result in the carryover of degradants or microbial contamination that may adversely alter the established API impurity profile. Production operations should be conducted in a manner that will prevent contamination Reprocessing Reworking Batches that have been reworked should be subjected to appropriate evaluation, testing, stability testing if warranted, and documentation to show that the reworked product is of equivalent quality to that produced by the original process.
Concurrent validation is often the appropriate validation approach for rework procedures. This allows a protocol to define the rework procedure, how it will be carried out, and the expected results. If there is only one batch to be reworked, then a report can be written and the batch released once it is found to be acceptable.
Procedures should provide for comparing the impurity profile of each reworked batch against batches manufactured by the established process. Where routine analytical methods are inadequate to characterize the reworked batch, additional methods should be used. Recovery of Materials and Solvents All quality related complaints, whether received orally or in writing, should be recorded and investigated according to a written procedure.
Records of complaints should be retained in order to evaluate trends, product-related frequencies, and severity with a view to taking additional, and if appropriate, immediate corrective action.
There should be a written procedure that defines the circumstances under which a recall of an intermediate or API should be considered. The recall procedure should designate who should be involved in evaluating the information, how a recall should be initiated, who should be informed about the recall, and how the recalled material should be treated.
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ICH Q7 Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients
ICH Q7 Good manufacturing practice for active pharmaceutical ingredients
This document is intended to provide guidance regarding good manufacturing practice GMP for the manufacturing of active pharmaceutical ingredients APIs under an appropriate system for managing quality. It is also intended to help ensure that APIs meet the quality and purity characteristics that they purport, or are represented, to possess. In this guidance, the term manufacturing is defined to include all operations of receipt of materials, production, packaging, repackaging, labeling, relabeling, quality control, release, storage and distribution of APIs and the related controls. In this guidance, the term should identifies recommendations that, when followed, will ensure compliance with CGMPs. An alternative approach may be used if such approach satisfies the requirements of the applicable statutes. For the purposes of this guidance, the terms current good manufacturing practices and good manufacturing practices are equivalent.
U.S. Food and Drug Administration