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Good Documentation Practice
Good documentation practice (commonly abbreviated GDP, recommended to abbreviate as GDocP to distinguish from "good distribution practice" also abbreviated GDP) is a term in the pharmaceutical and medical device industries to describe standards by which documents are created and maintained. While some GDP / GDocP standards are codified by various competent authorities, others are not but are considered cGMP (with emphasis on the "c", or "current"). Some competent authorities release or adopt guidelines, and they may include non-codified GDP / GDocP expectations. While not law, authorities will inspect against these guidelines and cGMP expectations in addition to the legal requirements and make comments or observations if departures are seen. In the past years, the application of GDocP is also expanding to cosmetic industry, excipient and ingredient manufacturers. GDP / GDocP standards Documentation creation * Contemporaneous with the event they describe * Not handwritten ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Drug Distribution
The distribution of medications has special drug safety and security considerations. Some drugs require cold chain management in their distribution. The industry uses track and trace technology, though the timings for implementation and the information required vary across different countries, with varying laws and standards. Regulation Because governments regulate access to drugs, governments control drug distribution and the drug supply chain more than trade for other goods. Distribution begins with the pharmaceutical industry manufacturing drugs. From there, intermediaries in the public sector, private sector, and non-governmental organizations acquire drugs to provide them to other intermediaries. Eventually, the drugs reach different classes of consumers who use them. Good distribution practice (GDP) is a quality warranty system, which includes requirements for purchase, receiving, storage and export of drugs intended for human consumption. It regulates the division an ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Correction Fluid
A correction fluid is an opaque, usually white fluid applied to paper to mask errors in text. Once dried, it can be handwritten or typed upon. It is typically packaged in small bottles, lids attached to brushes (or triangular pieces of foam) that dip into the fluid. The brush applies the fluid to the paper. Before the invention of word processors, correction fluid greatly facilitated the production of typewritten documents. One of the first forms of correction fluid was invented in 1956 by American secretary Bette Nesmith Graham, founder of Liquid Paper. With the advent of colored paper stocks for office use, manufacturers began producing their fluids in various matching colors, particularly reds, blues and yellows. Composition The exact composition of correction fluid varies between manufacturers, but most fluids are composed of an ''opacifying agent'', a ''solvent'' (or thinner) and an adulterant 'fragrance' to discourage abuse. The opacifying agent can be composed of a ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Site Master File
Pharmaceutical manufacturing is the process of industrial-scale synthesis of pharmaceutical drugs as part of the pharmaceutical industry. The process of drug manufacturing can be broken down into a series of unit operations, such as milling, granulation, coating, tablet pressing, and others. Scale-up considerations Cooling While a laboratory may use dry ice as a cooling agent for reaction selectivity, this process gets complicated on an industrial scale. The cost to cool a typical reactor to this temperature is large, and the viscosity of the reagents typically also increases as the temperature lowers, leading to difficult mixing. This results in added costs to stir harder and replace parts more often, or it results in a non-homogeneous reaction. Finally, lower temperatures can result in crusting of reagents, intermediates, and byproducts to the reaction vessel over time, which will impact the purity of the product. Stoichiometry Different stoichiometric ratios of reagents can ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Best Practice
A best practice is a method or technique that has been generally accepted as superior to other known alternatives because it often produces results that are superior to those achieved by other means or because it has become a standard way of doing things, e.g., a standard way of complying with legal or ethical requirements. Best practices are used to maintain quality as an alternative to mandatory legislated standards and can be based on self-assessment or benchmarking. Best practice is a feature of accredited management standards such as ISO 9000 and ISO 14001. Some consulting firms specialize in the area of best practice and offer ready-made templates to standardize business process documentation. Sometimes a best practice is not applicable or is inappropriate for a particular organization's needs. A key strategic talent required when applying best practice to organizations is the ability to balance the unique qualities of an organization with the practices that it has in common ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Ditto Mark
The ditto mark is a shorthand sign, used mostly in hand-written text, indicating that the words or figures above it are to be repeated. The mark is made using 'a pair of apostrophes'; 'a pair of marks used underneath a word'; the symbol (quotation mark); but the Cambridge Dictionary of Business English on the same page uses the CJK ditto mark or the symbol (right double quotation mark). In the following example, the second line reads "Blue pens, box of twenty". Black pens, box of twenty ... $2.10 Blue " " " " ... $2.35 History Early evidence of ditto marks can be seen on a cuneiform tablet of the Neo-Assyrian period (934–608 BCE) where two vertical marks are used in a table of synonyms to repeat text. In China the corresponding historical mark was two horizontal lines (also the symbol of "two"), found in bronze script from the Zhou Dynasty, as in the example at right (circa 825 BCE). In script form this became , and is now written as ; see iteration ma ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Asterisk
The asterisk ( ), from Late Latin , from Ancient Greek , ''asteriskos'', "little star", is a typographical symbol. It is so called because it resembles a conventional image of a heraldic star. Computer scientists and mathematicians often vocalize it as star (as, for example, in ''the A* search algorithm'' or ''C*-algebra''). In English, an asterisk is usually five- or six-pointed in sans-serif typefaces, six-pointed in serif typefaces, and six- or eight-pointed when handwritten. Its most common use is to call out a footnote. It is also often used to censor offensive words. In computer science, the asterisk is commonly used as a wildcard character, or to denote pointers, repetition, or multiplication. History The asterisk has already been used as a symbol in ice age cave paintings. There is also a two thousand-year-old character used by Aristarchus of Samothrace called the , , which he used when proofreading Homeric poetry to mark lines that were duplicated. Origen is know ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Post-it Note
A Post-it Note (or sticky note) is a small piece of paper with a re-adherable strip of glue on its back, made for temporarily attaching notes to documents and other surfaces. A low-tack pressure-sensitive adhesive allows the notes to be easily attached, removed and even re-posted elsewhere without leaving residue. Originally small yellow squares, Post-it Notes and related products are available in various colors, shapes, sizes and adhesive strengths. As of 2019, there are at least 26 documented colors of Post-it Notes. Although 3M's patent expired in 1997, "Post-it" and the original notes' distinctive yellow color remain registered company trademarks, with terms such as "repositionable notes" used for similar offerings manufactured by competitors. While use of the trademark 'Post-it' in a representative sense refers to any sticky note, no legal authority has ever held the trademark to be generic. History In 1968, Dr. Spencer Silver, a scientist at 3M in the United States, ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Calendar Date
A calendar date is a reference to a particular day represented within a calendar system. The calendar date allows the specific day to be identified. The number of days between two dates may be calculated. For example, "25 " is ten days after "15 ". The date of a particular event depends on the observed time zone. For example, the air attack on Pearl Harbor that began at 7:48 a.m. Hawaiian time on 7 December 1941 took place at 3:18 a.m. Japan Standard Time, 8 December in Japan. A particular day may be assigned a different nominal date according to the calendar used, so an identifying suffix may be needed where ambiguity may arise. The Gregorian calendar is the world's most widely used civil calendar, and is designated (in English) as AD or CE. Many cultures use religious or regnal calendars such as the Gregorian ( Western Christendom, AD), Hebrew calendar (Judaism, AM), the Hijri calendars ( Islam, AH), Julian calendar ( Eastern Christendom, AD) or any other o ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Seal (East Asia)
A seal, in an East and Southeast Asian context, is a general name for printing stamps and impressions thereof which are used in lieu of signatures in personal documents, office paperwork, contracts, art, or any item requiring acknowledgement or authorship. On documents they were usually used to print an impression using a pigmented paste or ink, unlike the wax impression commonly used in Europe. Of Chinese origin, the process soon spread beyond China and across East and Southeast Asia. Various countries in these regions currently use a mixture of seals and hand signatures, and, increasingly, electronic signatures. Chinese seals are typically made of stone, sometimes of metals, wood, bamboo, plastic, or ivory, and are typically used with red ink or cinnabar paste (). The word 印 ("yìn" in Mandarin, "in" in Japanese and Korean, "ấn" and "in" in Vietnamese) specifically refers to the imprint created by the seal, as well as appearing in combination with other morphemes in wo ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Audit Trail
An audit trail (also called audit log) is a security-relevant chronological record, set of records, and/or destination and source of records that provide documentary evidence of the sequence of activities that have affected at any time a specific operation, procedure, event, or device. Audit records typically result from activities such as financial transactions, scientific research and health care data transactions, or communications by individual people, systems, accounts, or other entities. The process that creates an audit trail is typically required to always run in a privileged mode, so it can access and supervise all actions from all users; a normal user should not be allowed to stop/change it. Furthermore, for the same reason, the trail file or database table with a trail should not be accessible to normal users. Another way of handling this issue is through the use of a role-based security model in the software. The software can operate with the closed-looped controls, o ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Validation (drug Manufacture)
Validation is the process of establishing documentary evidence demonstrating that a procedure, process, or activity carried out in testing and then production maintains the desired level of compliance at all stages. In the pharmaceutical industry, it is very important that in addition to final testing and compliance of products, it is also assured that the process will consistently produce the expected results. The desired results are established in terms of specifications for outcome of the process. Qualification of systems and equipment is therefore a part of the process of validation. Validation is a requirement of food, drug and pharmaceutical regulating agencies such as the US FDA and their good manufacturing practices guidelines. Since a wide variety of procedures, processes, and activities need to be validated, the field of validation is divided into a number of subsections including the following: *Equipment validation *Facilities validation *HVAC system validation *Cleaning ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Document
A document is a written, drawn, presented, or memorialized representation of thought, often the manifestation of non-fictional, as well as fictional, content. The word originates from the Latin ''Documentum'', which denotes a "teaching" or "lesson": the verb ''doceō'' denotes "to teach". In the past, the word was usually used to denote written proof useful as evidence of a truth or fact. In the computer age, "document" usually denotes a primarily textual computer file, including its structure and format, e.g. fonts, colors, and images. Contemporarily, "document" is not defined by its transmission medium, e.g., paper, given the existence of electronic documents. "Documentation" is distinct because it has more denotations than "document". Documents are also distinguished from " realia", which are three-dimensional objects that would otherwise satisfy the definition of "document" because they memorialize or represent thought; documents are considered more as 2-dimensional rep ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
