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Posts by THE ADMINISTRATOR   |   for Drugs / Biologics   |  Posted on Thursday,May 09,13,05:14 AM

USP method transfer underwent a change when the US Pharmacopeia published the final version of its informational chapter 1224, which deals with the transfer of analytical procedures mentioned in the document entitled USP 35-NF 30. This became official in May 2012.
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Posts by THE ADMINISTRATOR   |   for Drugs / Biologics   |  Posted on Thursday,May 09,13,05:12 AM

USP 1058 analytical instrument qualification is about ensuring that an instrument is suitable for its intended use and application. While system suitability and method validation activities have specific guidelines and procedures; analytical instrument qualification is not so specific. There are conflicting opinions and viewpoints regarding USP 1058 analytical instrument qualification.
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Posts by THE ADMINISTRATOR   |   for Drugs / Biologics   |  Posted on Thursday,May 09,13,04:53 AM

In lay terms, sterilization is understood in a number of ways. We have sterilization in economics, in family planning and in many other fields. When it comes to this term as used by the FDA; there is a specific purpose and definition. For the FDA, sterilization process controls are indispensable for validation.
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Posts by THE ADMINISTRATOR   |   for Drugs / Biologics   |  Posted on Thursday,May 09,13,04:20 AM

Q7 guidelines are those guidelines issued by the ICH (International Conference on Harmonization) in relation to Good Manufacturing Practices (GMP) for Active Pharmaceutical Ingredient (API).
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Posts by THE ADMINISTRATOR   |   for Drugs / Biologics   |  Posted on Thursday,May 09,13,04:05 AM

A method transfer is the process of qualifying a laboratory regarding its ability to carry out an analytical test procedure. For method transfer, FDA has some regulations that are simple on the face of it, but require many steps and precautions. Not being in compliance with these steps could invite investigation and corrective measures to ensure that validated method transfer is carried out.
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Posts by THE ADMINISTRATOR   |   for Medical & Surgical   |  Posted on Thursday,May 09,13,03:40 AM

A Master Production Record (MPR) is one of the several important documents that a manufacturer of finished pharmaceuticals has to maintain and furnish. It is one of the indispensable parts of pharmaceutical good manufacturing practices (GMP’s). FDA's regulations on Master Production Record (MPR) are found in Code of Federal Regulations (CFR)’s Title 21, Volume 4. The current standard was revised on April 1, 2012.
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Posts by THE ADMINISTRATOR   |   for Medical & Surgical   |  Posted on Thursday,May 09,13,03:36 AM

Being the global standard for quality management systems in medical devices; ISO 13485 has many controls and checks built in at various stages of the product design and development. One of these is the ISO 13485 statistical techniques procedure. This is a means to ensuring that product characteristics and process capability are measured and checked in a statistical manner to ensure their conformity with the relevant global standards.
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Posts by THE ADMINISTRATOR   |   for Medical & Surgical   |  Posted on Thursday,May 09,13,03:34 AM

ISO 13485 has purchasing procedures for suppliers. ISO 13485 purchasing procedure is listed in Section 7.4 and its sub sections. The outstanding feature of this section is that the ISO is not clear about the expected levels of control a supplier has to have in place. It simply states that a documented procedure is required for purchasing and that the purchased products have to be compliant with specified requirements. This leaves scope for a lot of ambiguity and subjectivity in the ISO 13485 purchasing procedure.
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Posts by THE ADMINISTRATOR   |   for Medical & Surgical   |  Posted on Thursday,May 09,13,03:31 AM

ISO 13485 is the blueprint for quality management in medical devices. Design and development being very critical components of a medical device; ISO 13485 design and development is considered a very important section relating to this aspect of a medical device. Being the extant standard; the ISO 13485 standard has superseded a number of previous standards.
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Posts by THE ADMINISTRATOR   |   for Medical & Surgical   |  Posted on Thursday,May 09,13,02:00 AM

ISO 13485 2003 is the global standard that concerns itself with quality management for medical devices.
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Posts by THE ADMINISTRATOR   |   for Drugs / Biologics   |  Posted on Thursday,May 09,13,01:38 AM

The ICH Q7 is a globally harmonized GMP guideline for Active Pharmaceutical Ingredients (API). This guideline covers all GMP aspects of manufacturing, quality control and trading of both chemical and biological ingredients of a drug.
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Posts by THE ADMINISTRATOR   |   for Drugs / Biologics   |  Posted on Wednesday,May 08,13,06:19 AM

ICH guidelines for API are guidelines from the ICH specific to the active pharmaceutical ingredient (API) of the drug.
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Posts by THE ADMINISTRATOR   |   for Drugs / Biologics   |  Posted on Wednesday,May 08,13,04:45 AM

As an ICH guideline, Q7 takes a primary position. ICH guideline Q7 relates to the whole range of Good Manufacturing Practice (GMP) for a human drug’s Active Pharmaceutical Ingredient (API) covering the US, the EU and Japan. Originally called the ICH Q7A; these guidelines were issued in November 2000 by the International Conference on Harmonization (ICH).
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Posts by THE ADMINISTRATOR   |   for Medical & Surgical   |  Posted on Wednesday,May 08,13,04:05 AM

FDA guidance on method transfer is a kind of conundrum. On the one hand, there should be no complexity in analytical method transfer because the nature of method transfer is simple. On the other hand; there are no clearly defined guidelines on the subject from the FDA, making it something of a system that is free wheel in grand self-contradictory. The fact that the FDA is not the only regulatory body that has guidelines on method transfer adds to the lack of a straight jacketed approach to the topic.
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Posts by THE ADMINISTRATOR   |   for Medical & Surgical   |  Posted on Wednesday,May 08,13,03:58 AM

The Canadian Medical Device Regulations (CMDR) is the guidance that classifies medical devices in Canada.
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Posts by THE ADMINISTRATOR   |   for Medical & Surgical   |  Posted on Wednesday,May 08,13,03:52 AM

The Global Harmonization Task Force (GHTF) is deemed with the task of issuing guidance documents on medical device risk classification. Its classification is made based on the risk level the medical device poses. The US, Canada and the EU are covered in the Task Force’s guidance.
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Posts by THE ADMINISTRATOR   |   for Food   |  Posted on Wednesday,May 08,13,02:06 AM

BRC, short for British Retail Consortium, is a body that sets global safety standards for food. Its standards are part of a leading safety and quality certification program. With a membership of over 17,000 certified suppliers in more than 90 countries, BRC works through a coordinated network of over 80 accredited or recognized certification bodies.
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Posts by THE ADMINISTRATOR   |   for Food   |  Posted on Wednesday,May 08,13,01:57 AM

BRC risk analysis is about the guidelines issued by the international risk analysis body, the British Retail Consortium (BRC). Being a product of deliberations over a long period of time; BRC is today a global food safety standards body that is hard on risk analysis. This makes BRC risk analysis a unique proposition that stands apart from its US audit standards.
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Posts by THE ADMINISTRATOR   |   for Drugs / Biologics   |  Posted on Tuesday,May 07,13,01:39 AM

Theoretically speaking, analytical method transfer guidelines from FDA are quite simple. The logic behind analytical method transfer guidelines from FDA is like this: in its elementary form, analytical method transfer is the way by which a laboratory becomes qualified to use a test procedure.
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Posts by THE ADMINISTRATOR   |   for Drugs / Biologics   |  Posted on Thursday,Mar 28,13,04:22 AM

One of the landmark legislations of the US Congress, the Orphan Drug Act, completed three decades of its existence in the first week of January, 2013. At the time of its passage, it was hailed as a milestone for the pharmaceutical industry. This was mainly because the Act gave American pharmaceutical companies and researchers major incentives for producing orphan drugs –drugs that are used for treating rare diseases.
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Posts by THE ADMINISTRATOR   |   for Medical & Surgical   |  Posted on Thursday,Mar 28,13,03:55 AM

The MDUFA stands for Medical Device User Fee and Modernization Act. This term is quite self-explanatory. It means the fee the FDA collects from medical device manufacturers to review medical devices and drugs before they get approved to enter the market.
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Posts by THE ADMINISTRATOR   |   for Drugs / Biologics   |  Posted on Monday,Mar 25,13,04:10 AM

CORE Network is the FDA's comprehensive plan aimed at managing outbreak response and coordinating post-response activities. CORE Network stands for Coordinated Outbreak Response and Evaluation Network.
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Posts by THE ADMINISTRATOR   |   for Drugs / Biologics   |  Posted on Monday,Mar 25,13,03:59 AM

Given the enormity of foodborne infections that Americans face –close to 50 million affected every year, over 100,000 of whom get hospitalized; and nearly 3,000 deaths –there is a need for authorities to come up with something more than symptomatic treatments.
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Posts by THE ADMINISTRATOR   |   for Medical & Surgical   |  Posted on Tuesday,Mar 19,13,04:31 AM

One of the most common questions that medical device manufacturers face is about when to make new 510 (K) –relating to premarket notification –submissions when changes are made into the product. A 510 (K) submission has to be made not only for every new product, but also whenever there is an update into the product.
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Posts by THE ADMINISTRATOR   |   for Medical & Surgical   |  Posted on Tuesday,Mar 19,13,04:14 AM

If manufacturing a medical device is one thing; marketing it is an altogether different one. It obviously goes without saying that a manufactured product is useless in itself unless it reaches the market. Marketing a medical device in the US entails having to carry out many steps, all of which need to be properly done and carried out at the appropriate time. What are the steps the FDA expects from a manufacturer of a medical device?
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Posts by THE ADMINISTRATOR   |   for Drugs / Biologics   |  Posted on Tuesday,Mar 19,13,04:03 AM

The FDA, being the regulatory body in the US, is alone authorized to approve drugs. One of the FDA's centers, the Center for Drug Evaluation and Research (CDER) is charged with ensuring that drugs –both prescription and over-the-counter drugs –that enter the market are safe for consumption and meet their intended use.
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Posts by THE ADMINISTRATOR   |   for Food   |  Posted on Tuesday,Mar 19,13,03:51 AM

As one of the leading economies of the world with all-round development; the US attaches an extremely high degree of importance to food safety. Since large sections of the diverse population eats food that is prepared from various sources; the public has a tendency for contracting foodborne illnesses.
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Posts by THE ADMINISTRATOR   |   for Food   |  Posted on Monday,Mar 18,13,07:14 AM

The FDA regulates food meant for both humans and pets. Regulating animal food is done through its wing, the Center for Veterinary Medicine (CVM). This center is charged with regulating a variety of animal-related food products such as animal drugs, and feed ingredients, food additives, medicated feeds. Code of Federal Regulations (CFR), Title 21 has regulations relating to animal food.
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Posts by THE ADMINISTRATOR   |   for Food   |  Posted on Tuesday,Oct 30,12,12:41 AM

Foreign material control is critical for the US food industry. American consumers are very wary when it comes to food contamination, given their predisposition to diseases such as cancer. US authorities try to contain contamination in consumers’ food for a number of reasons. Foreign material control is important because:
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Posts by THE ADMINISTRATOR   |   for Medical & Surgical   |  Posted on Monday,Oct 29,12,05:57 AM

A supplier audit program is a must-have in medical devices and pharmaceutical manufacturers, especially those that outsource their processes. Being such an important element in the supply chain; a supplier audit program is the driving force towards ensuring quality and consistency in the supply chain, and is a very important component of the quality.
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Posts by THE ADMINISTRATOR   |   for Drugs / Biologics   |  Posted on Monday,Oct 29,12,05:40 AM

A pharmaceutical drug consists of the API and the excipient, the inert substance
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Posts by THE ADMINISTRATOR   |   for Drugs / Biologics   |  Posted on Monday,Oct 29,12,05:24 AM

Since nutraceuticals are preventives, FDA is less stringent in enforcing regulations on nutraceuticals than on drugs
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Posts by THE ADMINISTRATOR   |   for Medical & Surgical   |  Posted on Monday,Oct 29,12,05:00 AM

Good glucose control using home monitors lead to fewer complications
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Posts by THE ADMINISTRATOR   |   for Medical & Surgical   |  Posted on Monday,Oct 29,12,04:15 AM

The Design History File (DHF) is a critical document for a medical device. The DHF is a record of a series of documents that explain the design history of a medical device. In other words, it is a documentation of the way by which the inputs that went into the medical device manufacture worked in a preset process to arrive at the final product.
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Posts by THE ADMINISTRATOR   |   for Drugs / Biologics   |  Posted on Monday,Oct 29,12,01:52 AM

Compliance is monitored by the bodies that enact different compliance standards and laws.
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Posts by THE ADMINISTRATOR   |   for Medical & Surgical   |  Posted on Monday,Oct 29,12,01:17 AM

These are medical devices and other accessories that are used to perform tests on samples that are extracted from the living organisms
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Posts by THE ADMINISTRATOR   |   for Drugs / Biologics   |  Posted on Monday,Oct 29,12,12:46 AM

Understanding the secrets of DNA is the key to the next generation of medical care involving extremely personalized treatment
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Posts by THE ADMINISTRATOR   |   for Drugs & Biologics   |  Posted on Friday,Oct 26,12,06:21 AM

The aim is to improve people’s health around the world
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Posts by THE ADMINISTRATOR   |   for Medical & Surgical   |  Posted on Thursday,Oct 25,12,05:04 AM

This device could make emergency care for cardiac patients much easier and accessible
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Posts by THE ADMINISTRATOR   |   for Medical & Surgical   |  Posted on Thursday,Oct 25,12,04:51 AM

For anyone in the medical devices industry; the real buzzword perhaps is ISO 13485:2003. What is it? How does it matter to the industry? What are its exceptions?
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Posts by THE ADMINISTRATOR   |   for Medical & Surgical   |  Posted on Thursday,Oct 25,12,04:06 AM

The E-cigarette has the potential to alter smoking habits and wean heavy smokers away
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Posts by THE ADMINISTRATOR   |   for Medical & Surgical   |  Posted on Thursday,Oct 25,12,03:48 AM

An internal audit program is needed for any business in which continuous work is needed, such as documentations. An audit ensures that the root cause of documentation is addressed. Documentation that is proper and process-oriented is a regulatory requirement, and hence an audit program is a must. A proper audit program that has tied loose ends up is a guarantee against any check from an external source, such as the FDA or an internal one, such as by the management or the firm’s partners.
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Posts by THE ADMINISTRATOR   |   for Drugs / Biologics   |  Posted on Thursday,Oct 25,12,02:29 AM

This new medical procedure looks like a promising, permanent alternative to medications and other treatments
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Posts by THE ADMINISTRATOR   |   for Medical & Surgical   |  Posted on Friday,Oct 19,12,02:08 AM

Risk Management is a critical factor in IEC 60601-1 Third Edition. This is one of the important additions that have been made to this edition from the previous one. The new legislation requires that Risk Management be implemented in the product lifecycle throughout the standard.
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Posts by THE ADMINISTRATOR   |   for Medical & Surgical   |  Posted on Friday,Oct 19,12,01:04 AM

Regulatory compliance training is an important element of Continuing Professional Education (CPE). As the title suggests, CPE is for professionals who have been in the industry for a few years, and who need to keep upgrading and enhancing their skill sets to meet changing industry needs, requirements and challenges.
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Posts by THE ADMINISTRATOR   |   for Medical & Surgical   |  Posted on Friday,Oct 19,12,12:48 AM

On August 10, 2012, the FDA issued new guidelines on Refuse to Accept Policy for 510(k)’s. This updated guideline, which is currently a draft, will supersede earlier guidelines on the subject, namely Center for Devices and Radiological Health’s Premarket Notification (510(k)) Refuse to Accept Policy, dated June 30, 1993, and 510(k) Refuse to Accept Procedures (K94-1) blue book memo, dated May 20, 1994 when completed.
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Posts by THE ADMINISTRATOR   |   for Drugs & Biologics   |  Posted on Thursday,Oct 18,12,05:30 AM

QBD stands for Quality by Design. ICH Q8 (R), Step 2 defines QBD as “A systematic approach to development that begins with predefined objectives and emphasizes product and process understanding and process control, based on sound science and quality risk management”. QBD in analytical method development is an important component, as we will see later.
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Posts by THE ADMINISTRATOR   |   for Drugs / Biologics   |  Posted on Thursday,Oct 18,12,05:09 AM

ICH Q8 (R2) describes the nature of Quality by Design (QBD). QBD is a systematic approach to pharmaceutical manufacturing and development. Based on exact science with incontrovertible evidence, QBD aims at bringing about product and process understanding and process control. QBD seeks to bring all these about by beginning with predefined objectives.
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Posts by THE ADMINISTRATOR   |   for Medical & Surgical   |  Posted on Thursday,Oct 18,12,04:20 AM

There are doubts about whether dental devices will be as effective when they are procured from developing countries at half or a third of their price
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Posts by THE ADMINISTRATOR   |   for Medical & Surgical   |  Posted on Thursday,Oct 18,12,04:01 AM

Medical compliance, rather lack of it, is perhaps the most detested word for the medical fraternity. Medical compliance is, in simple terms, adherence to prescribed treatment. Many patients fail their doctors by not following treatment courses properly.
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Posts by THE ADMINISTRATOR   |   for Medical & Surgical   |  Posted on Thursday,Oct 18,12,03:48 AM

Which are the DHF requirements that the FDA looks for? DHF requirements are a very important part of the DHF. The DHF shows conformance with design controls as specified under FDA’s 21 CFR 820.30 and Sub-clause 4.4 of ISO 9001.
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Posts by THE ADMINISTRATOR   |   for Medical & Surgical   |  Posted on Thursday,Oct 18,12,02:07 AM

One of the most commonly countered questions in the medical device industry is: ISO 13485 vs. ISO 9001. They are often confused for each other. But they are never the same, although they have many common requirements.
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Posts by THE ADMINISTRATOR   |   for Medical & Surgical   |  Posted on Thursday,Oct 18,12,01:28 AM

Each and every organization that implements ISO 13485, an important ISO standard, has to have a Quality Manual in place. The ISO 13485 sets out requirements for a complete management system for organizations that are in the business of designing and manufacturing of medical devices.
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Posts by THE ADMINISTRATOR   |   for Medical & Surgical   |  Posted on Wednesday,Oct 17,12,04:28 AM

So, you are in the medical devices industry, and one of the first items you would come across in your profession is having to deal with an ISO 13485 audit. What is the ISO 13485, and what does it take to audit it?
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Posts by THE ADMINISTRATOR   |   for Medical & Surgical   |  Posted on Wednesday,Oct 17,12,04:11 AM

Gap analysis is an important aspect of the ISO 13485 audit. The ISO 13485 standard lists out requirements for a wide-ranging management system for the manufacture and design of medical devices. When a medical device organization performs a gap analysis, it is analyzing the gaps that exist in its QMS vis-à-vis that prescribed in ISO 13485.
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Posts by THE ADMINISTRATOR   |   for Medical & Surgical   |  Posted on Wednesday,Oct 17,12,03:49 AM

The IEC, which stands for International Electrotechnical Commission, dates its founding to more than a century back, to 1906. It is the world’s leading voluntary organization for regulation of the technologies that collectively go into electronic components and are bunched together as electrotechnology.
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Posts by THE ADMINISTRATOR   |   for Drugs / Biologics   |  Posted on Tuesday,Oct 16,12,06:24 AM

The ICH Q 7 A is a globally harmonized GMP guideline for Active Pharmaceutical Ingredients (API). This guideline covers all GMP aspects of manufacturing, quality control and trading of both chemical and biological ingredients of a drug.
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Posts by THE ADMINISTRATOR   |   for Drugs / Biologics   |  Posted on Tuesday,Oct 16,12,04:34 AM

Good Documentation Practices (GDP), although indispensable for GMP practices; often gets overlooked. In relation to CAPA, validation, investigation and such other practices; GDP seems to be getting the scantest attention. Important though these programs are; none of them is complete without GDP or is a substitute for it.
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Posts by THE ADMINISTRATOR   |   for Food   |  Posted on Tuesday,Oct 16,12,04:28 AM

Since foreign material control is a matter of grave importance to the American public, there are several Good Manufacturing Processes (GMP’s) that are in place for this industry. As defined by the FDA; GMP’s for foreign material control include facility, processing and employee practices aimed primarily at microbial control, but also foreign material control. The reason for which GMP’s have to be put in place in the foreign material control area is that they ensure food security. These are some of them:
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Posts by THE ADMINISTRATOR   |   for Medical & Surgical   |  Posted on Tuesday,Oct 16,12,03:55 AM

The IEC 60601-1 Third Edition has a major clause. This is an addition to the existing regulation. Accordingly, an electronic medical device has to conform to the ISO14971 regulations, which relate to risk management. According to this regulation, a medical device manufacturer has to implement risk management during the product life cycle to ensure the product’s safety.
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Posts by THE ADMINISTRATOR   |   for Food   |  Posted on Tuesday,Oct 16,12,02:24 AM

Putting a foreign material detection system in place is very important. Consider this: in investigations conducted over a period of about a quarter century; the FDA Health Hazard Evaluation Board found out that less than three per cent of objects of the size of over six mm were said to present no hazard. Also, around fifty per cent of objects in the range of one to six mm pose a limited acute hazard, meaning that even such small objects are essentially unsafe.
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Posts by THE ADMINISTRATOR   |   for Food   |  Posted on Tuesday,Oct 16,12,02:15 AM

Foreign Material (FM) Control is often a source of major problem for the food industry in the US, as a good part of consumer complaints across the food industry in the country relates to FM inclusion in finished food products. This issue has been one of considerable debate too, in not only the industry, but society itself as a whole. It involves food, without which no human can survive, and hence the controversy.
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Posts by THE ADMINISTRATOR   |   for Drugs / Biologics   |  Posted on Tuesday,Oct 16,12,02:03 AM

An FDA Warning Letter is a means for enforcing compliance among manufacturers in the regulated industry
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Posts by THE ADMINISTRATOR   |   for Drugs / Biologics   |  Posted on Tuesday,Oct 16,12,01:19 AM

Initiative became necessary in view of increased complaints about these devices
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Posts by THE ADMINISTRATOR   |   for Drugs / Biologics   |  Posted on Tuesday,Oct 16,12,01:12 AM

An FDA guidance, as the title suggests, is a set of suggestions from the FDA on a number of its governing areas. The FDA, being a regulatory body sets standards for almost every conceivable area. It is almost impossible to list the number of guidances the FDA has issued.
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Posts by THE ADMINISTRATOR   |   for Drugs / Biologics   |  Posted on Tuesday,Oct 16,12,12:56 AM

The FDA guidance on process validation is an important document that offers guidelines on Process Validation (PV), a critical aspect of medical device and pharmaceutical manufacturing.
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Posts by THE ADMINISTRATOR   |   for Drugs / Biologics   |  Posted on Monday,Oct 15,12,12:34 AM

The FDA Guidance on Analytical Method describes analytical method or procedure thus: "The analytical procedure refers to the way of performing the analysis. It should describe in detail the steps necessary to perform each analytical test. This may include but is not limited to: the sample, the reference standard and the reagents preparations, use of the apparatus, generation of the calibration curve, use of the formulae for the calculation, etc."

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