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The intent of this Validation Master Plan (VMP) is to provide a written plan for establishing documented evidence of the suitability of the facilities, reliability and consistency of the equipment, and validity of the manufacturing process. This VMP shall be used during the design and commissioning of a plant. The VMP is a framework for gathering documentation and conducting qualification studies necessary to fulfill fundamental philosophies of Good Manufacturing Practices in pharmaceutical manufacturing, such as:

  The US Food and Drug Administration (FDA) has declined to approve Novo Nordisk's insulin degludec , issuing instead a "complete response letter" in which it requests additional cardiovascular-outcomes data from a dedicated trial. In a statement, the company says it is evaluating the content of the complete response letter and will work closely with the FDA to provide the requested data, which it does not anticipate being able to do in 2013. Mike Rulis, a spokesperson for Novo Nordisk, told  Medscape Medical News : "This is all the detail we can give at this point. We hope to have a meeting with the FDA, sooner rather than later, to discuss this further."

As a further safety measure against the emerging Zika virus outbreak, today the U.S. Food and Drug Administration issued a revised guidance recommending universal testing of donated Whole Blood and blood components for Zika virus in the U.S. and its territories. “There is still much uncertainty regarding the nature and extent of Zika virus transmission,” said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research. “At this time, the recommendation for testing the entire blood supply will help ensure that safe blood is available for all individuals who might need transfusion.” The FDA first   issued guidance on Feb. 16   recommending that only areas with active Zika virus transmission screen donated Whole Blood and blood components for Zika virus, use pathogen-reduction devices, or halt blood collection and obtain Whole Blood and blood components from areas of the U.S. without active virus transmission. All areas with active trans...

Hormone replacement therapy (HRT) with a combination of estrogen and progestogen (although not HRT with estrogen alone) increases the risk of  breast cancer to a much greater extent than has previously been reported, and the longer the duration of use, the greater the risk, new research shows. "Our research shows that some previous studies are likely to have underestimated the risk of breast cancer with combined oestrogen-progestogen HRT," senior author, Anthony J. Swerdlow, MD, professor of epidemiology, the Institute of Cancer Research (ICR), London, United Kingdom (UK), said in a statement.

Adding oranges, limes, and lemons into your diet may be the health trick we’ve been looking for to fight off the steady increase of   obesity-related diseases   in America. A new study, presented at the American Chemical Society’s 252nd National Meeting & Exposition, has revealed the previously underestimated benefits citrus fruits could have for the roughly  80 million obese people   in the United States.  Knowing that citrus fruits are packed with heart-healthy   antioxidants , a team of researchers from the Universidad Estadual Paulista tested how far its benefits could go. For one month they fed a group of 50 mice a standard diet, a high-fat diet, or a high-fat diet mixed with flavanones, which are a class of antioxidants found in   oranges , lemons, and limes. Compared to the standard diet, the mice that were fed a high-fat diet experienced an increase damage in the blood by 80 percent and the liver by 57 percent. However, the mice t...

About HACCP Hazard Analysis and Critical Control Points (HACCP) is a process control system designed to identify and prevent microbial and other hazards in food production. It includes steps designed to prevent problems before they occur and to correct deviations as soon as they are detected. Such preventive control systems with documentation and verification are widely recognized by scientific authorities and international organizations as the most effective approach available for producing safe food. The Seven HACCP Principles Principle 1 : Conduct a hazard analysis. Plants determine the food safety hazards identify the preventive measures the plant can apply to control these hazards.

AADA: Abbreviated antibiotic drug application ADE: Adverse drug event ADME: Absorption, distribution, metabolism, and excretion AHU: Air Handling Unit ANDA: Abbreviated new drug application ANVISA: Agencia Nacional de Vigilancia Sanitaria (National Health Surveillance Agency Brazil) AP: Applicants Part (of EDMF) API: Active pharmaceutical ingredient APR: Annual product review (APQR – Annual product quality          Review) AQL: Acceptable quality level AR: Analytical Reagent ASHRAE: American Society of heating, Refrigeration and Air Conditioning Engineers ASM: Active Substance Manufacturer ASMF: Active Substance Master File AST: Accelerated stability testing ASTM: American Society for Testing and Materials BA/BE: Bioavailability/bioequivalence BCS: Biopharmaceutical classification system BET: Bacterial...

A brief description on AHU Air handling unit is a device used to condition and circulate air as part of a heating, ventilating, and air-conditioning (HVAC) system. An air handler is usually a large metal box containing a blower, heating or cooling elements filter racks or chambers, sound attenuators, and dampers. Air handlers usually connect to a ductwork ventilation system that distributes the conditioned air through the building and returns it to the AHU. Sometimes AHUs discharge (supply) and admit (return) air directly to and from the space served without ductwork. Small air handlers, for local use, are called terminal units, and may only include an air filter, coil, and blower; these simple terminal units are called blower coils or fan coil units. A larger air handler that conditions 100% outside air, and no recalculated air, is known as a makeup air unit (MAU). An air handler designed for outdoor use, typically on roofs, is known as a packaged uni...

Tooling Storage: Ø   Store Tooling in Dies & Punches room in designated racks with tooling storage rack label after applying a thin smear of lubricant oil over the punch and die surface. Ø   Fill out a new Tooling Storage Rack Label for new set with the following information: a)      Rack number b)      Set Number c)       Product name & Strength d)      Punch dimensions e)      Punch specification f)        Tooling D/B/BB g)      Quantity h)      Embossing on Upper punch i)         Embossing on Lower punch j)         Checked by NOTE: For plain tooling, meaning there is no embossing on the face of the tooling, the word “plain” shall be noted. Ø   Once all verifications are complete, ...

Appearance Defects: Capping: -  ‘Capping’ is the term used, when the upper or lower segment of the tablet separates horizontally, either partially or completely from the main body of a tablet and comes off as a cap, during ejection from the tablet press, or during subsequent handling. Lamination :   ‘Lamination’ is the separation of a tablet into two or more distinct horizontal layers. Sticking/filming :   ‘Sticking’ refers to the tablet material adhering to the die wall. Filming is a slow form of sticking and is largely due to excess moisture in the granulation. Cracking:-   Small fine cracks observed on the upper and lower center surface of the tablets, or very rarely on the side wall are referred to as cracks. Chipping:-  ‘ Chipping’ is defined as the breaking of tablet edges, while the tablet leaves the press or during subsequent handling and ...

Appearance Defects: Capping: -  ‘Capping’ is the term used, when the upper or lower segment of the tablet separates horizontally, either partially or completely from the main body of a tablet and comes off as a cap, during ejection from the tablet press, or during subsequent handling. Lamination :   ‘Lamination’ is the separation of a tablet into two or more distinct horizontal layers. Sticking/filming :   ‘Sticking’ refers to the tablet material adhering to the die wall. Filming is a slow form of sticking and is largely due to excess moisture in the granulation. Cracking:-   Small fine cracks observed on the upper and lower center surface of the tablets, or very rarely on the side wall are referred to as cracks. Chipping:-  ‘ Chipping’ is defined as the break...

Not more than two of the individual weights can deviates from the average weight by more than the percentage given in the pharmacopeia and none can deviate more than twice that percentage. Weight Variation limits for Tablets: IP/BP Limit    USP 80 mg or less 10% 130mg or less More than 80mg or Less than 250mg 7.5% 130mg to 324mg 250mg or more 5% More than 324mg Weight Variation limits for Capsules: IP Limit Less than 300mg 10% 300mg or More 7.5%

While calibrating DT apparatus, following checks shall be performed. 1.) Number of strokes per minute (Limit: 29-32 cycles/min) 2.) Temperature by probe & standard thermometer (Limit:  37 ± 1  O C). 3). Distance travelled by basket (Limit: 53 -57mm)

An equipment or instrument can ‘drift’ out of accuracy between the time of qualification and actual use.So it is recommended to calibrate and recalibrate the measuring devices and instruments on predetermined time intervals, to gain confidence on the accuracy of the data.

The number of batches produced in the validation exercise should be sufficient to allow the normal extent of variation and trends to be established and to provide sufficient data for evaluation and reproducibility. ·       First batch quality is accidental (co-incidental), ·       Second batch quality is regular (accidental), ·       Third batch quality is validation (confirmation). In 2 batches we cannot assure the reproducibility of data, 4 batches can be taken but the time and cost are involved.

Calibration is a demonstration that, a particular Instrument or device produces results within specified limits by comparisons with those produced by a reference or traceable standard over an appropriate range of measurements. Whereas Validation is a documented program that provides a high degree of assurance that a specific process, method or system consistently produces a result meeting pre-determined acceptance criteria. In calibration performance of an instrument or device is comparing against a reference standard. But invalidation such reference standard is not using. Calibration ensures that instrument or measuring devices producing accurate results. Whereas validation demonstrates that a process, equipment, method or system produces consistent results (in other words, it ensures that uniforms batches are produced).                     ...

Full registration dossier consists of 5 modules: 1. Module 1: ADMINISTRATIVE INFORMATION 1.1 Table of contents. 1.2. Application form. 1.3. Summary of product characteristics, labelling and instructions for medical use: 1.3.1. Summary of product characteristics. 1.3.2. Labelling. 1.3.3. Instructions for medical use. 1.3.4. Mock-ups and specimens. 1.3.5. Summary of product characteristics already approved in the manufacturer/applicant-country. 1.4. Information about the independent experts: 1.4.1. Information about the quality expert. 1.4.2. Information about the pre-clinical expert. 1.4.3. Information about clinical expert. 1.5 Specific requirements for different types of applications. Annex to Module 1. Environmental risk assessment MODULE 2: CTD SUMMARY 2.1. Table of contents of Modules 2 – 5. 2.2. Introduction. 2.3. Quality overall summary. 2.4. Pre-clinical overview: 2.5. Clinical overview 2.6. Pre-clinical summary 2.6.1. Pharmacology written summary....

Full registration dossier consists of 5 modules: 1. Module 1: ADMINISTRATIVE INFORMATION 1.1 Table of contents. 1.2. Application form. 1.3. Summary of product characteristics, labeling and instructions for medical use: 1.3.1. Summary of product characteristics. 1.3.2. Labeling. 1.3.3. Instructions for medical use. 1.3.4. Mock-ups and specimens. 1.3.5. Summary of product characteristics already approved in the manufacturer/applicant-country. 1.4. Information about the independent experts: 1.4.1. Information about the quality expert. 1.4.2. Information about the pre-clinical expert. 1.4.3. Information about  the  clinical  expert. 1.5 Specific requirements for different types of applications. Annex to Module 1. Environmental risk assessment MODULE 2: CTD SUMMARY 2.1. Table of contents of Modules 2 – 5. 2.2. Introduction. 2.3. Quality overall summary. 2.4. Pre-clinical overview: 2.5. Clinical overview 2.6. Pre-clinical summary 2.6.1. Pharmacology ...