Release certificate

Insofar as the provisions laid down in (a), (b) or (c) are complied with, investigational medicinal products shall not have to undergo any further checks if they are imported into another Member State together with batch release certification signed by the qualified person. 

The release of software is documented with a release certificate created by the QA team in cooperation with product management, which also creates the release notes for each product version. This document describes the enhancements and modifications finally implemenfed info fhe new product version. Prominent chapters of the release notes are — if applicable to the respective product version — new functions, modules, and configurations, changed functionality, functions that are no longer supported, as well as technical implications that require a change in the software environment (e.g., a new version of a database server). Release notes often include a list of known issues that have not been solved in the released version. 

Batch testing is carried out to verify prepreg properties, such as resin content, volatile level, and flow. The resin advancement (chemical reaction) is monitored via a Differential Scanning Calorimeter (DSC) and the formulation consistency by testing the Tg via DSC or Dynamic Mechanical Analyzer (DMA). The laminate properties are also determined. All are documented and quoted on a Release Certificate. 

The two liter carbon canister does not exhibit the HC release during the run loss portion of the test, nor does it release more than the allowable level of HC during the three day diumals. Thus, for the given vehicle configuration and the level of purge volume obtained by the vehicle, it is clear that a two liter carbon canister is required for this vehicle to pass the EPA certification requirement. This conclusion has an effect on the cost of the evaporative control system, in that the additional activated carbon volume and canister size will have an added cost, as will any additional hardware required to mount the larger canister on the vehicle. 

This requirement poses something of a dilemma when purchasing subcontract labor because it cannot be treated the same as product. You still need to ensure, however, that the labor conforms with your requirements before use. Such checks will include verification that the personnel provided have the requisite qualifications, skills, and knowledge and they are who they say they are. These checks can be made on the documentary evidence provided, such as certificates, but you will probably wish to monitor their performance because it is the effort you have purchased, not the people. You will not be able to verify whether they are entirely suitable until you have evaluated their performance. Subcontract labor could be classified as product released prior to verification being performed and so you need to keep records of the personnel and their performance during the tenure of the contract. 

Annex 16 Certification by a Qualified person and Batch Release Annex 17 Parametric Release... 

The first four materials (IRMM/IFCC-452, 453, 454, 455) are expected to be released during 2000. Projects on the certification of reference materials for cardiac marker (myoglobin) and total protein concentration in serum are under discussion. Even so the number of available CRMs for clinical chemistry and occupational toxicology is still limited. This has to do with the complexity of physiological compounds (e.g. proteins), the instabihty (e.g. enzymes), or the volatility (e.g. solvents). 

Evolution of analytical techniques can cause data, once considered to be state of the arf to be shown to be unreliable. A good example is provided by the work of Houba et al. (1995), who demonstrated that a number of older methods for the determination of trace levels of boron in plant materials were subject to the interference by high levels of copper. This and other evidence suggest that older data, even when presented on a certificate, have to be viewed critically see also Section 3.2. The analyst must stay aware of developments and be ready to disregard certified values if the date of certification of the CRM predates the release of new developments and the certification authority concerned cannot confirm that the certified value is good in the light of the new knowledge. 

Sweeteners are food additives by definition in almost all countries and need approval for use by food laws, food regulations, decrees or certificates released and issued by the national government or other responsible governmental institutions. Generally three prerequisites must be fulfilled to obtain an approval for use ... 

Risk management plan contents executive summary registration worst-case data alternative release data five-year accident history prevention program data emergency response data certification. 

Internal failure cost is the cost when you discover, before release a laboratory report or an analysis certificate that something has gone wrong. 

After successful vendor auditing, it can be determined whether purchased ingredients and materials can be accepted on the basis of suppliers certificates, with minimized inspections of incoming goods to a certain level. Vendor certification leads to reduction of costs and release times. 

Components are received and are quarantined in ABC Pharmaceutical Industries stores until all testing and certificate of analysis requirements are reviewed and have met the acceptance criteria set forth in manufacturing site standard operating procedures. When all acceptance criteria have been met, the components are released by Quality Control and are ready to be issued for production using the procedures specified in manufacturing site standard operating procedures. 

Annex 16 Certification by a qualified person and batch release... 

Reportedly, the MEG can be fabricated using only conventional tools and techniques already used by many major manufacturers. All the parts and materials to construct an MEG are available commercially. On October 18, 2000, its development was also announced to selected staff personnel of two Senate Committees. A 69-page MEG technical report, presently on a private DOE Website for DOE evaluation, explains the principles and concepts used by this new-energy generator. Arrangements are also in process for formal independent certification tests by a major university under U.S. government auspices, followed by full formal independent replication under proprietary release agreement. 

The apparatus suitability test described in USP General Chapter <711> Dissolution is equivalent to a performance qualification.5 The determination of suitability of a test assembly to perform dissolution testing must include conformance to the dimensions and tolerances of the apparatus. In addition, the critical test parameters that have to be monitored periodically include volume and temperature of the dissolution medium, rotation speed (Apparatuses 1 and 2), dip rate (Apparatus 3), and flow rate of medium (Apparatus 4). This test requires that the USP Calibrator Tablets (now known as Performance Verification Standard Tablets) be tested the dissolution results must be within the ranges stated in the certificate of the calibrator tablets. The performance verification standard tablets include USP Chlorpheniramine Maleate Extended-Release Tablets RS, USP Prednisone Tablets RS, and USP Salicylic Acid Tablets RS. 

Required submission of samples of each manufactured lot of all biologicals for government testing and certification prior to commercial release... 

In the EEC, applications or notifications for clinical trials have to be lodged with the individual national authorities. A common procedure or even mutual recognition of clinical trial certificates does not exist. A list of the different national requirements is provided in "The Rules Governing Medicinal Products in the European Communities" Volume III, Annex 1. A discussion paper (III/ 3044/91) released in 1991 by the EEC Division for Pharmaceuticals (DG III) addresses various issues on the harmonization of approval of clinical trials and may eventually lead to common, non-binding recommendations. 

Pharmacy Technician Certification Board. PTCB and NABP working together fact sheet, 2002, pp. 1-3. Available at www.ptcb.org/releases/ PTCB%20NABP%20Q A.html, accessed August 20, 2002. 

European Union, Annex 16 — Certification by a Qualified Person and Batch Release, European Union Guide to Directive 91/356/EEC. 

A requirement, in line with Regulation (EC) No 1935/2004, concerning a declaration of compliance and the availability of appropriate documentation, has been confirmed in the draft regulation. It means that for any active and intelligent material a statement shall be provided that certifies that the material is safe to be used in contact with food under specified conditions of contact. To support such a statement the certifier shall have documentation that can prove the validity of the certificated. These documents shall be available to relevant authorities for inspection. In many cases this will include analytical data on, e.g., migration, total release, and effectivity of the active and intelligent of active components. 

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