Good Manufacturing Practice or GMP shall mean any and all laws, rules, regulations, guidelines and generally accepted standards and requirements regarding the quality control and manufacturing of pharmaceutical products, including without limitation the CFR Title 21, ICH GMP Guidelines Q7, current step 4 version, dated 10 November 2000, as amended from time to time, national legislation implementing European Community Directive 91/356/EEC of 13 June 1991 laying down the principles and guidelines of good manufacturing practice for medicinal products for human use as amended by European Community Directives 2003/94/EC, the Rules Governing Medicinal Products in the European Community, Volume 4, including annexes.
Good Manufacturing Practice. Manufacturing of FMT-like products and defined LBPs intended for oral or rectal administration (and thus, likely based on anaerobic organisms) has a few shared challenges. These include minimizing exposure to oxygen, in particular in steps of the process where the organisms are metabolically active and preserving the viability of bacterial cells during processing and storage. A variety of factors influence the viability of bacteria during the manufacturing process and subsequent storage, including oxygen exposure, growth media, shearing, composition of the buffer solutions used to suspend the bacteria before freezing or freeze-drying, cooling rate, and freeze-thaw cycles, among others. The problem of maintaining cell viability during freezing and particularly during freeze-drying for long term storage deserves special attention, as it is one of the most technically challenging steps of manufacturing an LBP. During freezing and freeze-drying, the bacterial cell wall is exposed to mechanical forces due to formation of ice crystals inside and outside the cell, which can disrupt the membrane and kill the cell. During freeze-drying, furthermore, the process of removing water by sublimation generates osmotic pressures that can damage the cell membrane. Optimization of freeze- drying cooling cycles and development of buffer solutions containing cryoprotectants or lyoprotectants is therefore an important step to ensure the long-term preservation of LBPs. While preservation conditions for a number of aerobes and some facultative anaerobes such as E. coli, and Lactobacillus and Lactococcus species has been described in the literature, there is very little published on the topic of preservation of anaerobic gut commensals [32]. Further complicating the matter of long-term preservation of LBPs, the efficiency of cooling regimes and cryoprotectant and lyoprotectant substances can be highly bacterial species-specific. There are certain manufacturing considerations that are unique to FMT-like products. Feces are a heterogenous substance composed of bacteria, viruses, fungi, food, and host secretions, which does not naturally yield itself to precise characterization. Consequently, manufacturing considerations emphasize rigorous donor screening and processing of stool donations, and relatively de-emphasize in-depth characterization of the composition, which would vary with every donation. FMT is performed using suspensions made of donor stool from carefully selected and sc...
Good Manufacturing Practice. Each Collaboration Product, regardless of the form or formulation delivered by the Manufacturing Party, shall be Manufactured by the Manufacturing Party in accordance with GMP and the specifications for such Collaboration Product. *Certain information on this page has been omitted and filed separately with the commission. Confidential treatment has been requested with respect to the omitted portions.
Good Manufacturing Practice or GMP shall mean any and all laws, rules, regulations, guidelines and generally accepted standards and requirements regarding the quality control and manufacturing of pharmaceutical products promulgated or endorsed by a Regulatory Authority of competent jurisdiction, including the relevant regulations set forth in CFR Title 21, ICH GMP Guidelines Q7, current step 5 version, dated 10 November 2000, as amended from time to time, national legislation implementing European Community Directive 91/356/EEC of 13 June 1991 laying down the principles and guidelines of good manufacturing practice for medicinal products for human use as amended by European Community Directives 2003/94/EC, the Rules Governing Medicinal Products in the European Community, Volume 4, including annexes. GxP means GCP, GLP or GMP or any combination thereof, as applicable.
Good Manufacturing Practice. APG shall manufacture, store and prepare all Products for shipping in accordance with cGMPs, in an FDA inspected facility, currently envisioned to be APG's facilities in Indiana, located at 1919 Superior Street, Elkhart, Indiana (formulation and cxxxxxxxxxx; xx xxxxxxx xxxxxxx; xxxxxxed product testing) and 2825 Middlebury Street, Elkhart, Indiana (fill and packagxxx). XXX xxxxx xxxxxx xxxx xxx xxxxxxxxping and maintenances of each facility complies with cGMP requirements. APG may not change manufacturing of Products to an alternate facility without first obtaining Connetics' written approval, including the approvals required pursuant to the Quality Agreement, such approval not to be unreasonably withheld.
Good Manufacturing Practice. INyX shall manufacture, store and prepare all Products for shipping in accordance with the current Good Manufacturing Practices ("cGMPs") of the FDA, and the equivalent manufacturing requirements of the European Regulatory Authorities, in an FDA inspected and ISO9000 certified facility, currently envisioned to be INyX's facility in Runcorn, U.K. INyX may not change manufacturing of Products to an alternate facility without first obtaining the Customer's written approval, including the approvals required pursuant to the Quality Agreement, such approvals not to be unreasonably withheld.
Good Manufacturing Practice. [93] A point in dispute is the impact of Glaxo's GMP. The appellant submits that the Glaxo ranitidine and that purchased by generic companies are not comparable because of the differences in GMP and HSE standards. The respondent agrees that there may be differences in GMP and HSE but states that those differences are of no significance to either safety or efficacy and therefore should have no bearing on the purchase price of ranitidine. [94] GMP is a term used for the control and management of manufacturing and quality control testing of foods and pharmaceutical products. The appellant's expert, Xx. Xxxxxxx Xxxx, a senior regulatory compliance consultant who was a branch director of the U.S. Food and Drug Administration ("FDA") until 1999, described GMP as: policies, practices, written procedures that companies establish to ensure that the whole production process, which includes manufacturing, testing and release, reduces as much as possible the risk to that product having – being adulterated, having harmful impurities, et cetera, in it. [95] In the view of Xxxxx Xxxxxx, Glaxochem Limited's purchasing manager between 1988 and 1994, GMP: …means that you are running your site efficiently with good housekeeping. You have trained personnel operating it. You are keeping full and comprehensive records of all your manufacture, all your batch records. You are doing proper chemical analysis on all the materials that you buy in, that you use in process. You segregate materials that are rejected that you bought in and only use good ones, and you can track a manufacturer right the way through from beginning to end and you know who has done what to it at what time and did it comply with a manufacturing process that was registered. [96] A total of five science experts were called, all of whom attempted to put their testimony in xxxxxx'x terms, to varying degrees of success. With respect to these issues the following facts are clear:
Good Manufacturing Practice. The University’s Animal Care and Use program does not conduct studies subject to the FDA Good Laboratory Practice (GLP) regulations. As a result, nonclinical studies conducted at the University are not GLP studies. Since the University does not incorporate GLP into its standard animal care, results obtained from animal studies at the University cannot be described as GLP compliant and should not be so described in applications to the FDA or in other documents. In addition, the University does not conduct studies subject to the FDA Good Manufacturing Practice (GMP) regulations and results obtained cannot be described as GMP compliant.
Good Manufacturing Practice. Each Party shall promptly notify the other Party upon becoming aware of any material amendments of, or additions to, cGMP that could affect the Services to be performed by OXB under this Agreement and applicable Scope of Work or Work Order. The Parties shall confer with each other about the best means of complying with such amendments or additions. Changes to the Scope of Work or Work Order resulting from changes to cGMP may be proposed by either Party in writing to the other Party, but shall take effect only subject to the signature by both Parties of an appropriate Change Order; provided that OXB shall use commercially reasonable efforts to implement any reasonable change to the Services required as a result of any amendment or addition to cGMP (“Required cGMP Change”). OXB shall bear the cost of any Required cGMP Change if such change applies to the services OXB provides to other clients or otherwise applies to OXB’s business as a contract manufacturing organization generally. Any other Required cGMP Changes shall be for the sole cost of Client, unless otherwise agreed under the applicable Change Order. Notwithstanding the foregoing, OXB shall not be required to act in any way in contravention of any newly implemented legal or other regulatory requirements.
Good Manufacturing Practice. To the Knowledge of the Company, the inventory of the Company of key materials, reagents, active pharmaceutical ingredients, compounds and products, has been manufactured, handled, stored and distributed in accordance in all material respects with applicable Legal Requirements, including current “Good Manufacturing Practice,” or cGMP regulations.
