Site Master File definition
means a document prepared by the manufacturer containing specific and factual good manufacturing practice information about the production and/or control of pharmaceutical manufacturing operations carried out at a named site and any closely integrated operations at adjacent and nearby buildings;
Based on 6 documents
means a document prepared by the wholesaler or distributor
Based on 2 documents
means the documentation required as part of the licensing procedures (market authorization) by any Regulatory Body having jurisdiction over such licensing, for the Plasma-Derived Products, including, without limitation, details of the manufacturing building, location, construction, service facilities and environment, which is kept in an independent file;
Based on 2 documents
Examples of Site Master File in a sentence
- A «full inspection report» comprises a Site Master File (compiled by the manufacturer or by the inspectorate) and a narrative report by the inspectorate.
- A ‘full inspection report’ comprises a Site Master File (compiled by the manufacturer or by the inspectorate) and a narrative report by the inspectorate.
- A Site Master File should be succinct and, as far as possible, not exceed approximately twenty-five to thirty A4 pages.
- REQUIRED GMP DOCUMENTATION (BY TYPE) Site Master File: A document describing the GMP related activities of the manufacturer.
- In the area of organic farming, implementing legislation on controls and registers was adopted in 2013.
- These Explanatory Notes apply to the preparation of the Site Master File.
- The Site Master File should have an edition number and an effective date.
- The Responsible Pharmacist is to maintain and update the Site Master File.
- Written procedures should be in place for the preparation, review and update of the Site Master File.
- A list identifying the subjects by subject number will be kept in the Site Master File.
More Definitions of Site Master File
means a document that contains specific information about the quality assurance, the production and/or quality control of pharmaceutical manufacturing operations carried out at the Foreign Site and any closely integrated operations at adjacent and nearby buildings. The guidance document entitled « Explanatory Notes for Industry on the Preparation of a Site Master File » (xxxx://xxx.xx- xx.xx.xx/xxx-xxx/xxxxxx-xxxxxxx/xxxxxxxx/xxxxxxxxxx/xxx_0000_xx-xx-xxx.xxx) may be consulted for further guidance.
Based on 2 documents
means a document prepared by a manufacturer which provides information about the production and control of manufacturing operations
Based on 1 documents
Related to Site Master File
- Master File has the meaning set forth in the CAISO Tariff.
- Drug Master File or “DMF” is described in 21 C.F.R. Part 314.420. A DMF is a submission to the FDA that may be used to provide confidential detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of one or more human drugs.
- Death master file means the United States social security administration’s death master file or any other database or service that is at least as comprehensive as the United States social security administration’s death master file for determining that a person has died.
- DMF means a Drug Master File for Captisol, as filed as of the Effective Date, or as hereafter updated from time to time during the Term, by CyDex with the FDA.
- Phase I Clinical Study means, as to a particular Licensed Product, an initial clinical study in humans with the purpose of assessing the Licensed Product’s safety, tolerability, toxicity, pharmacokinetics or other pharmacological properties.
- HEPA filter means high-efficiency particulate air filters that are rated to achieve a minimum initial particle-removal efficiency of 99.97 per cent using ASTM F 1471– 93 or equivalent standard;
- Central Contractor Registration (CCR) database means the primary Government repository for Contractor information required for the conduct of business with the Government.
- CREFC® Special Servicer Property File The data file in the “CREFC® Special Servicer Property File” format substantially in the form of and containing the information called for therein for the Mortgage Loans, or such other form for the presentation of such information as may be approved from time to time by the CREFC® for commercial mortgage securities transactions generally.
- Database Management System (DBMS) A system of manual procedures and computer programs used to create, store and update the data required to provide Selective Routing and/or Automatic Location Identification for 911 systems. Day: A calendar day unless otherwise specified. Dedicated Transport: UNE transmission path between one of CenturyLink’s Wire Centers or switches and another of CenturyLink’s Wire Centers or switches within the same LATA and State that are dedicated to a particular customer or carrier. Default: A Party’s violation of any material term or condition of the Agreement, or refusal or failure in any material respect to properly perform its obligations under this Agreement, including the failure to make any undisputed payment when due. A Party shall also be deemed in Default upon such Party’s insolvency or the initiation of bankruptcy or receivership proceedings by or against the Party or the failure to obtain or maintain any certification(s) or authorization(s) from the Commission which are necessary or appropriate for a Party to exchange traffic or order any service, facility or arrangement under this Agreement, or notice from the Party that it has ceased doing business in this State or receipt of publicly available information that signifies the Party is no longer doing business in this State.
- Covered contractor information system means an information system that is owned or operated by a contractor that processes, stores, or transmits Federal contract information.
- Phase I Clinical Trial means a human clinical trial that is intended to initially evaluate the safety and/or pharmacological effect of a Product in subjects or that would otherwise satisfy requirements of 21 C.F.R. 312.21(a), or its foreign equivalent.
- Data Site means an electronic password protected data site maintained by the Borrower (or by the Collateral Manager on behalf of Borrower) at Xxxxxxx Corporation, Intralinks, SyndTrak Online or any other similar electronic distribution system reasonably acceptable to the Administrative Agent.
- Contractor information system means an information system belonging to, or operated by or for, the Contractor.
- Research record means any data, document, computer file, computer diskette, or any other written or non-written account or object that reasonably may be expected to provide evidence or information regarding the proposed, conducted, or reported research that constitutes the subject of an allegation of research misconduct. A research record includes, but is not limited to, grant or contract applications, whether funded or unfunded; grant or contract progress and other reports; laboratory notebooks; notes; correspondence; videos; photographs; X-ray film; slides; biological materials; computer files and printouts; manuscripts and publications; equipment use logs; laboratory procurement records; animal facility records; human and animal subject protocols; consent forms; medical charts; and patient research files.
- Death master file match means a search of the death master file or revised death master file which results in a match of the social security number or of the name and date of birth of an insured, annuity owner, or retained asset accountholder.
- Phase 4 Clinical Trial means a product support clinical trial of a Product that is commenced after receipt of MAA Approval in the country where such trial is conducted. Phase 4 Clinical Trial may include epidemiological studies, modeling and pharmacoeconomic studies and post-marketing surveillance trials.
- Prescription monitoring program means the electronic system within the Department of Health Professions that monitors the dispensing of certain controlled substances.
- Central fill pharmacy means a pharmacy contracting with an originating pharmacy, or having the same owner as an originating pharmacy, that provides centralized prescription drug order filling on behalf of the originating pharmacy pursuant to these rules.
- Data File means a single record or collection of data records that are logically related to each other, and are handled as a unit;
- health and safety file means a file, or other record containing the information in writing required by these Regulations «health and safety plan» means a site, activity or project specific documented plan in accordance with the client’s health and safety specification;
- Web Site means any point of presence maintained on the Internet or on any other public data network. With respect to any Website maintained on the World Wide Web, such Website includes all HTML pages (or similar unit of information presented in any relevant data protocol) that either (a) are identified by the same second-level domain (such as xxxxxxxxx.xxx) or by the same equivalent level identifier in any relevant address scheme, or (b) contain branding, graphics, navigation or other characteristics such that a user reasonably would conclude that the pages are part of an integrated information or service offering.
- Phase II Clinical Study means, as to a particular Licensed Product for a particular indication, a controlled and lawful study in humans of the safety, dose ranging and efficacy of such Licensed Product for such indication, which is prospectively designed to generate sufficient data (if successful) to commence a Phase III Clinical Trial of such Licensed Product for such indication.
- Phase 2 Clinical Trial means a human clinical trial of a product in any country that would satisfy the requirements of 21 C.F.R. 312.21(b) and is intended to explore a variety of doses, dose response, and duration of effect, and to generate initial evidence of clinical safety and activity in a target patient population, or a similar clinical study prescribed by the relevant Regulatory Authorities in a country other than the United States.
- Federal work authorization program means any of the electronic verification of work authorization programs operated by the United States Department of Homeland Security or any equivalent federal work authorization program operated by the United States Department of Homeland Security to verify information of newly hired employees, pursuant to the Immigration Reform and Control Act of 1986 (IRCA), D.L. 99-603.
- Approved clinical trial means a phase I, phase II, phase III, or phase IV clinical trial that is conducted in relation to the prevention, detection, or treatment of cancer or other life-threatening disease or Condition and is described in any of the following:
- Electronic Product Code™ (EPC) means an identification scheme for universally identifying physical objects via RFID tags and other means. The standardized EPC\TM\ data consists of an EPC\TM\ (or EPC\TM\ identifier) that uniquely identifies an individual object, as well as an optional filter value when judged to be necessary to enable effective and efficient reading of the EPC\TM\ tags. In addition to this standardized data, certain classes of EPC\TM\ tags will allow user-defined data. The EPC\TM\ Tag Data Standards will define the length and position of this data, without defining its content.
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Анализатор антенн и фидерных линий Anritsu Site Master S331E
Анализатор антенн и фидерных линий Anritsu Site Master S331E
Анализатор антенн и линий Anritsu Site Master S331E – это портативный прибор с наивысшими техническими характеристиками в прочной и надежной конструкции. Сочетая в себе последние достижения технологии, прибор S331E специально оптимизирован для полевых условий, прост в использовании и обеспечивает удобство управления данными измерений. Заряда батареи S331E хватает на весь рабочий день. Обладая большим 8.4” LCD сенсорным экраном, новым интуитивным пользовательским интерфейсом и классическим режимом работы (подобно интерфейсу S331D) анализатор S331E максимально повышает эффективность работы в полевых условиях.
Прибор Site Master S331E предназначен для подрядных организаций, интеграторов и поставщиков беспроводных услуг, для тех, кому необходим инструмент для снижения расходов по техническому обслуживанию своих площадок. Всем, кому нужно выполнять простые измерения антенн/линий и измерение мощности по достоинству оценят новый Site Master S331E. Простая конфигурация прибора без каких-либо опций и привлекательная стоимость является идеальным сочетанием для подрядчиков, выполняемых работы на антенных вышках. Прибор вполне доступен для закупки арендными организациями и формирования складских запасов партнерами.
С анализатором S331E нет необходимости тратить время на поиск сети питания, т.к. заряда батареи хватает на целый рабочий день, что в свою очередь обеспечивает большую продуктивность. Прибор также обладает большим объемом внутренней памяти, что позволяет не беспокоиться о количестве сохраняемых измерений. Ваши капитальные затраты сказываются на вашей прибыльности и стабильности. С помощью нового Site Master S331E, который обладает большой ценностью, вы можете существенно снизить эксплуатационные расходы.
Перевод «master file» на русский
The quality kept excellent with AVI format and you can reuse this master file to create other formats with great quality.
Качество сохранилось на высоком уровне с форматом AVI, и вы можете повторно использовать этот основной файл для создания других форматов с отличным качеством.
(b) Only having one vendor master file for the entire organization;
Ь) вести только один главный файл поставщиков для всей организации;
Furthermore the finalized OECD report requires each company within the MNE to keep a local and master file at its administrative department.
Кроме того, окончательный отчет ОЭСР требует, чтобы каждая компания в МНП хранила локальный и основной файл в своем административном отделе.
To request a hostname and an address and add a computer to the master file, users contacted the SRI’s Network Information Center (NIC), directed by Elizabeth Feinler, by telephone during business hours.
Чтобы запросить имя хоста и адрес и добавить компьютер в главный файл, пользователи связывались с сетевым информационным центром (NIC) SRI, руководимым Элизабет Фейнлер, по телефону в рабочее время.
Computers, including their hostnames and addresses, were added to the master file by contacting the SRI’s Network Information Center (NIC), directed by Elizabeth Feinler, by telephone during business hours.
Чтобы запросить имя хоста и адрес и добавить компьютер в главный файл, пользователи связывались с сетевым информационным центром (NIC) SRI, руководимым Элизабет Фейнлер, по телефону в рабочее время.
What is GMP, FDA, DMF and CEP?
The differences explained
Keeping that in mind, manufacturers and distributors must live up to certain high standards set by, for example, international agreements, their local government, or other organizations. In this article, we will be handling the main types of certificates or documents as present in the pharmaceutical world.
We made a video about it as well! You decide, watching or reading?
(text continues under the video)
What is GMP? (Good Manufacturing Practices)
GMP stands for Good Manufacturing Practices and is defined as “a system of manufacturing that guarantees reproducibility of product quality to set specifications.” It means being able to output a product with certain specifications consistently and documenting all steps in the process.
If there wasn’t such a system implemented, there would be no way of telling if a certain API or medicine has been produced according to the industry-set quality standards. That’s why the GMP system was introduced and is now the main standard in the pharmaceutical industry worldwide.
For a step-by-step guide on how to apply for a GMP certificate, check out our comprehensive article .
Different kinds of GMP / GMP are also known as:
cGMP: Adapting to Current Standards
- cGMP (current GMP)
Current GMP means that the company complies with the most recent requirements/version of GMP.
WHO GMP: A Global Perspective
- WHO GMP (World Health Organization GMP)
The WHO has its own guideline for GMP. More than 100 countries have incorporated the WHO GMP provisions into their national medicine law, and many more countries have adopted its provisions and approach in defining their own national GMP requirements.
Local, EU, and US GMP: Regional Variations
- Local/EU/US GMP
As with the WHO GMP, It specifies the authority that has audited the company. For example, to know the difference between a Chinese GMP certificate and an EU-GMP certificate, you have to check the difference in GMP requirements of both authorities.
If you are interested in GMP, check out our blog, discussing GMP in detail and the differences between GMP/cGMP.
What is FDA ? (Food and Drug Administration)
FDA’s Global Impact
The Food and Drug Administration is a federal agency of the United States Department of Health and Human Services, one of the United States federal executive departments.
F DA is important because it intends to have companies produce their goods to certain standards and presents this fact in a clear overview using FDA certificates. When a company is (US) FDA approved, it shows the American government has declared the API or medicine safe and can be sold, imported, or used in the United States.
For more on how the FDA enforces these regulations, including issuing warning letters, you can read our detailed article on FDA Warning Letters .
The USA is not the only country with a regulatory agency like FDA. Most other countries have agencies responsible for the national safety of pharmaceutical products.
Some different kinds of organizations include:
- EMA (European Medicines Agency, European Union)
- MHRA (Medicines and Healthcare products Regulatory Agency, United Kingdom)
- PMDA (Pharmaceuticals and Medical Devices Agency, Japan)
- CDSCO (Central Drugs Standard Control Organization, India)
What is a DMF? (Drug Master File)
What Does a DMF Include?
A drug master file is a document submitted to governmental bodies that contains all details of the manufacturing process of an API or medicine. This includes information on the chemical properties of the API, the facilities used, the processes used, details on packaging, storage, et cetera. To protect the intellectual property of the manufacturer, this document is confidential.
Types of DMFs Around the World
Countries may have different guidance than other countries, so different types of DMF exist. For example, you may have a US DMF, ASMF (formally known as EDMF), Japanese DMF, Chinese DMF, et cetera.
What is ISO ?
International Organization for Standardization
ISO is the international organization for standardization. The organization promotes worldwide proprietary, industrial, and commercial standards. Organizations use the standard to demonstrate the ability to consistently provide products and services that meet customer and regulatory requirements. The ISO system pays more attention to the firm’s management and places a number of reporting loops in the firm to ensure attention to issues.
Different kinds of ISO:
- ISO 9001:2015 (a standard that specifies requirements for a quality management system)
- ISO 14001:2015 (a standard that focuses on managing environmental responsibilities)
- I SO 22000:2018 (a sector-specific standard that describes a specific process to develop a food safety management system)
- ISO 45001:2018 (is a new standard published in March 2018 that focuses on occupational health and safety. It is based on- and will be replacing the OHSAS 18001 standard throughout 2018 – 2021)
What is a CoA?
Certificate of Analysis
A CoA is a document issued by a company’s QA/QC-department that confirms that a product meets its product specification and is part of the quality control of a product batch. The CoA commonly contains results obtained from laboratory tests of an individual batch of a product. There are different international standards to which a product can be tested, for example:
- Ph. Eur. | EP – (European Pharmacopoeia)
- USP – (United States Pharmacopeia)
- BP – (British Pharmacopoeia)
- JP – (Japanese Pharmacopoeia)
- ChP – (Chinese Pharmacopoeia, also known as PPRC)
- DAB – (German Pharmacopoeia)
- Ph.Fr. – (French Pharmacopoeia)
- IP – (Indian Pharmacopoeia)
In general, there will be lots of overlap between the different qualities of a certain API. Certain limit values can differ according to the specific values set by different standards. A different monograph can also mean a different way of testing.
A technical data-sheet is not the same as a CoA, as it contains just the general product specifications and does not contain batch-specific results, which the CoA does.
What is an MSDS?
Material Safety Data Sheet
A Material Safety Data Sheet (MSDS) is a product-specific document intended as a reference for the safe use, handling, and processing of the product. It contains information such as identifiers, chemical properties, health hazards, precautionary statements, and other related information for professionals working with the product.
Internationally, there are different requirements for an MSDS, and an MSDS issued in the USA will differ from one issued in China. However, in recent years more and more companies have updated their MSDS to a GHS system(Globally Harmonized System of Classification and Labelling of Chemicals). The GHS is a standard managed by the United Nations (UN) and sets a certain structure for an SDS (16 sections), general statements for health hazards, common symbols, signal words, et cetera.
MSDS is also known as:
- SDS (Safety Data Sheet)
- PSDS (Product Safety Data Sheet)
For a deeper understanding of Safety Data Sheets, see our article on what an SDS is .
What is a CEP ?
Certificate of Suitability
A CEP (also known as COS) is a certificate that proves that an API qualifies for the relevant monograph of the European Pharmacopoeia. It links the Ph. Eur. monograph to the API itself. The manufacturer of the API submits a CEP as part of the market authorization process, and they will become the CEP holder of the document.
Being a European certificate, the CEP is granted by the EDQM but is recognized by other countries or institutes, such as the FDA in the US. Furthermore, just like the DMF, the data submitted in the CEP is handled strictly confidential and provides a centralized system recognized by many countries.
Other Certifications: Expanding the Horizons
KOSHER
This certification verifies that the ingredients and the production process comply with kashrut (Jewish dietary law) standards as defined in the Shulchan Aruch , a compilation of Jewish religious law. It is important because it ensures the product is produced within the norms and values of the Jewish religion.
HALAL
The Halal certificate is a document that guarantees that products and services are suitable for the Muslim population. When something is Halal-certified, It meets the requirements of Islamic law and is, therefore, suitable for consumption by the population that practices Islam.
What does BSE/TSE mean?
Bovine spongiform encephalopathy (BSE), commonly known as mad cow disease, is a neurodegenerative disease of cattle. Transmissible Spongiform Encephalopathies (TSE), also known as prion diseases, are a family of diseases occurring in humans and animals and are characterized by a degeneration of brain tissue, giving a sponge-like appearance leading to death.
This certificate declares that the product is free from animal-derived materials, including bovine products.
What does GMO mean?
Genetically Modified Organisms
Genetically Modified Organisms (GMO) are living organisms, and their genetic material has been artificially manipulated in a laboratory through genetic engineering. This creates combinations of plant-, animal-, bacteria-, and virus genes that do not occur in nature or through traditional breeding methods. Livestock and crops are the most common GMOs today; for example, livestock will be bred to develop muscle or fat, and crops will grow larger and faster.
Pharmaceutical and chemical companies that manufacture Non-GMO raw materials must have a statement ensuring the validity of all Non-GMO raw materials.
What is a WC?
Written Confirmation
When an API is imported into the European Union from elsewhere, it should be accompanied by a “written confirmation” (WC). A written confirmation is a document the country’s health authorities set up where the API was manufactured. After inspections were successfully performed under EU/GMP equivalent standards, the health authorities can provide a WC. These inspections will also have to take place in the future regularly.
Written Confirmations for API imports are not necessary when countries outside the EU are included in an official list of countries equivalent to the EU regarding GMP standards, inspections, and sanctions. So, countries on this list are exempt from needing a WC.
Japan, the United States, Brazil, Australia, Israel, Switzerland, and South Korea are the countries that have currently been granted exemption from a Written Confirmation, and there are a couple more countries that have applied. The list of these countries can be found on the website of the European Commission .
What is GDP?
Good Distribution Practice
GDP is a quality system for warehouses and distribution centers dedicated to pharmaceutical products. It focuses on the distribution of APIs and medicines. It controls the whole process, from the moment a product leaves the manufacturer to the point where it reaches the end-user. For example, GDP checks if all documentation is present and the goods are correctly stored. With storage, the temperature must be controlled and logged into a system.
In conclusion :
These are just a few of the certificates in the pharmaceutical industry, but they are the ones we found most relevant and are listed on the product pages here on Pharmaoffer.