Question List Related To The Topic: "Pharma"

Last Updated: 22 September, 2021

What is rld in pharma?

Answer: A Reference Listed Drug (RLD) is an approved drug product to which new generic versions are compared to show that they are bioequivalent. Reference Listed Drug (RLD) · 02. Reference Listed Drug (RLD) is an FDA approved drug product referred by Generic Drug Manufacturers while filling an ANDA, useful.. Know More

What is cgmp in pharma?

Answer: CGMP refers to the Current Good Manufacturing Practice regulations enforced by the FDA. Understanding Current Good Manufacturing Practices (cGMP) in the pharmaceutical industry can, at first, seem like trying to pick up a handful. The CGMP regulations for drugs contain minimum requirements for the. .. Know More

What is pfs in pharma?

Answer: The length of time during and after the treatment of a disease, such as cancer, that a patient lives with the disease but it does not get worse. Explore and engage with the evolving industry of pharmaceutical manufacturing related to PFS, from cross-site development to navigating. Pharmaceutical PFS.. Know More

What is ndds in pharma?

Answer: “Novel Drug delivery System (NDDS) refers to the formulations, systems and technologies for transporting a pharmaceutical compound in the body as it is needed to safely achieve its desired therapeutic effects. Novel Drug delivery System (NDDS) refers to the approaches, formulations, technologies, an.. Know More

What is trx in pharma?

Answer: NRx: This represents new prescriptions, meaning it is the first time a patient has been prescribed a particular drug. This is especially important for large field forces such as pharma, where a very. TRx (total prescriptions), NRx (total new prescriptions), and NBRx (new-to-brand prescriptions) have.. Know More

What is bpr in pharma?

Answer: Batch packaging record (BPR) is important document because it contains all information about the packaging process of the batch and requirement of GMP documentation. BATCH PACKING RECORD (BPR) BATCH PACKING RECORD (BPR) BMR Title : BPR for Tablet Document No. MPR BPR Defined: All cGMP manufacturers .. Know More

What is ipqa in pharma?

Answer: IPQA is determined by quality proceedings in standards and specifications of manufactured products to prevent mistakes, problems to customer services. Mottling:' Mottling' is the term used to describe an unequal distribution of colour on a tablet. IPQA Interview Questions · Ans: 1. Qualification:B P.. Know More

What is fdc in pharma?

Answer: A combination drug or a fixed-dose combination (FDC) is a medicine that includes two or more active ingredients combined in a single dosage form. The domestic pharmaceutical market size is pegged at around Rs 1. FDC has also set-up globally approved, multi-location manufacturing facilities for Activ.. Know More

What is qms in pharma?

Answer: A quality management system (QMS) is the core of any quality and compliance process. Today's most effective Quality Management Systems (QMS) for pharmaceutical companies simplify complex cGMP and compliance. Quality management system in pharmaceuticals helps to improve the product quality and minimi.. Know More

What is mhra in pharma?

Answer: The Medicines and Healthcare products Regulatory Agency (MHRA) is the government agency responsible for ensuring that medicines and medical devices work, and are acceptably safe. Full form of MHRA is Medicines and Healthcare products Regulatory Agency. Pharma IQ - Glossary - Medical and Healthcare P.. Know More

What is pcd pharma?

Answer: PCD – The full form of PCD is Propaganda cum Distribution. PCD full form is a widely asked question on the internet. Pharma PCD Companies - Looking for the top Pharma PCD Companies in india who are also doing monopoly based PCD franchise ? If yes then we'll gonna. PCD in its Full-form means Propagan.. Know More

What is oos in pharma?

Answer: The term OOS (out of specification), is defined as those results of in process or finished product testing, which falling out of specified limits, that are mentioned in compendia, drug master file, or drug application. SOP for Out of Specification (OOS) for Pharmaceutical Results. Out of specificati.. Know More

What is glp in pharma?

Answer: Good laboratory practice or GLP is a set of principles intended to assure the quality and integrity of non-clinical laboratory studies that are intended to support research or marketing permits for products regulated by government agencies. Learn the main parts of Good Laboratories Practice (GLP) as.. Know More

What is rsd in pharma?

Answer: Percent relative standard deviation (%RSD) is one such tool. RSD =Sample standard Deviation x 100/ Mean of data used = Mean x plus & minus value of RDS in percentage** OR in simple way %RSD is. RSD is a European company that manufactures and develops industrial sterilisation solutions for medical de.. Know More

What is cfr in pharma?

Answer: The Code of Federal Regulations (CFR) is a codification of the general and permanent rules published in the Federal Register by the Executive departments and agencies of the Federal Government. Title 21 of the CFR or the Code of Federal Regulations deals with governing of food and drugs in the Unite.. Know More

What is ksm in pharma?

Answer: The KSM plant which was commissioned in the year 2002 is a state-of-the-art facility to manufacture both the Key Starting Materials of Pantoprazole Sodium. India's PLI scheme intends to boost domestic production of bulk drugs including KSM, drug intermediaries, and APIs for antibiotics, steroids,. A.. Know More

What is pde in pharma?

Answer: in order to determine/calculate the Permitted Daily Exposure (PDE) for your active pharmaceutical ingredients (APIs) or critical excipients based on a pharmacological and toxicological evaluation in accordance with the revised GMP guideline and EMA's "Guideline on setting health based exposure limit.. Know More

What is qrm in pharma?

Answer: Quality risk management (QRM) is one of the most important tasks when it comes to pharmaceutical industry. Quality risk management (QRM) is one of the most important tasks when it comes to pharmaceutical industry. Standard operating procedure for quality risk assessment and quality risk management (.. Know More

What is fbd in pharma?

Answer: Fluidized bed dryer (also called fluid bed dryer) is a kind of equipment used extensively in the pharmaceutical industries to reduce the moisture content of pharmaceutical powder and granules. Fluidized bed dryer (FBD) is well known and widely used equipment in granulation area of pharmaceutical man.. Know More

What is wfi in pharma?

Answer: Water for injection (WFI) is used in the pharmaceutical industry to formulate parenteral drugs and for cleaning and other manufacturing operations. There are basically two types of water preparation in pharmaceuticals. What Water for Injection means for pharmaceutical industry. A form of normal phas.. Know More

What is qbd in pharma?

Answer: Pharmaceutical QbD is a systematic approach to development that begins with predefined objectives and emphasizes product and process understanding and control based on sound science and quality risk management (3). Quality by Design (QbD) is one of the most important initiative by US FDA. QUALITY BY.. Know More

What is gmp in pharma?

Answer: Good manufacturing practice (GMP) is a system for ensuring that products are consistently produced and controlled according to quality standards. Good Manufacturing Practice (GMP) Resources · GMP Resources · Training Options · Pharmaceutical Engineering Articles · Books, Manuals, and Guidance. What .. Know More

What is dqa in pharma?

Answer: WHAT IS DEVELOPMENTAL QUALITY ASSURANCE DEPARTMENT? · Imran Isahaque SheikhFollow · Imran Isahaque Sheikh · Pharma GXP. Job as a API DQA Expert at Dr. Mylan is one of the world's leading generics and specialty pharmaceutical companies, providing products to customers in more than 150 countries and t.. Know More

What is usfda in pharma?

Answer: United State Food and Drug Administration (USFDA) provides sterile and non- sterile pharmaceutical guidelines for industries. USFDA: The Food and Drug Administration (FDA) is an agency within the U. This page provides quick access to guidances documents for industry on pharmaceutical quality topics,.. Know More

What is eir in pharma?

Answer: EIR is basically a factual report on all the activities conducted by FDA investigators during the time spent at the manufacturing establishment. Breaking down the mechanics of an EIR from the US drug regulator, which the local pharma industry increasingly abides by. I wrote this EIR in its entirety... Know More

What is nrx in pharma?

Answer: NRx: This represents new prescriptions, meaning it is the first time a patient has been prescribed a particular drug. Meaning of NRx NRx as word or symbol is used for Schedule H narcotics drugs in india. Nrx refers to narcotic drugs prescription ,it cannot be refilled by pharmasist until a physician.. Know More

What is fbe in pharma?

Answer: Fluidized bed dryer (also called fluid bed dryer) is a kind of equipment used extensively in the pharmaceutical industries to reduce the moisture content of pharmaceutical powder and granules. FBE Series is a world-class range of fluid bed processors from ACG Pharma Technologies. It is ideal for hea.. Know More

What is rwe in pharma?

Answer: Congress defined RWE as data regarding the usage, or the potential benefits or risks, of a drug derived from sources other than traditional clinical trials. You have almost certainly heard the terms Real-World Data (RWD) and Real- World Evidence (RWE) – but are you still unsure about exactly what. R.. Know More

What is pob in pharma?

Answer: Take pob ( personal order booking ) from chemist on order pad. Ensure call norms of Doctors and Chemists are religiously met by everyone in the team day in and day out. WHAT IS CUTTING ,POB, DEAL. RCPA stands for Retail Chemist Prescription Audit. Pharma selling and sales marketing. Pharma Marketing.. Know More

What is dmf in pharma?

Answer: FDA provides info on DMF list, status of DMF, types of DMF, and more. Drug Master File or DMF is a document prepared by a pharmaceutical manufacturer and submitted solely at its discretion to the appropriate regulatory authority. While not required by law, a Drug Master File (DMF) is submitted to th.. Know More

What is nbrx in pharma?

Answer: New-to-brand (NBRx) may be a more valuable measure in differentiating between a true new patient—one who has never been on the brand before—and a new prescription. This is especially important for large field forces such as pharma, where a very large number of influencers are being targeted and sale.. Know More

What is cmc in pharma?

Answer: To appropriately manufacture a pharmaceutical or biologic specific manufacturing processes, product characteristics, and product testing must be defined in order to ensure that the product is safe, effective and consistent between batches. Oftentimes, the other half of the project -- the development.. Know More

What is aqa in pharma?

Answer: Pharma Aqa Jobs - Check out latest ✓ Pharma Aqa job vacancies @ monsterindia. We are looking for AQA Officer having experience in Pharma (API / Bulkdrugs) industry a. Walk In Interview for AQA, IPQA, QC, Microbiology at Sri Krishna Pharmaceuticals. Established in 2016, ANNORA Pharma is committed to .. Know More

What is hcp in pharma?

Answer: Healthcare profession (HCP) input is invaluable in drug development and maintaining pharma brand health, yet it's often hard won with key opinion leaders and high, likely prescribers. What do healthcare professionals want from pharmaceutical companies and how can the pharma industry successfully eng.. Know More

What is api in pharma?

Answer: An active ingredient is the ingredient in a pharmaceutical drug or pesticide that is biologically active. API (Active Pharmaceutical Ingredient) means the active ingredient which is contained in medicine. Active pharmaceutical ingredients (API) are the active ingredients in medications, carried by t.. Know More

How to prepare apqr in pharma?

Answer: Preparation of Annual Product Quality Review (APQR): Annual product report shall prepare for all finished products manufactured. APR to verify the consistency of the existing process, the appropriateness of current specifications for. . APR shall prepare for drug Products as per below time line and .. Know More

What is cqa in pharma?

Answer: Critical Quality Attributes (CQA) is defined by the FDA as a physical, chemical, biological, or microbiological property or characteristic that should be within an appropriate limit, range, or distribution to ensure the desired product quality (ICH Q8). A physical, chemical, biological or microbiolo.. Know More

What is msl in pharma?

Answer: The Medical Science Liaison (MSL) is a specialized role within the pharmaceutical, biotechnology, medical device, and related health-care fields. The Medical Science Liaison (MSL) is a specific role within the pharmaceutical, biotechnology, medical device, CRO and other healthcare industries. In pha.. Know More

What is ddd in pharma?

Answer: Definition and general considerations, To address this, a technical unit of measurement, the Defined Daily Dose (DDD) was created. Drug distribution data (DDD) lets you track the distribution of your branded products to retailers and non-retail buyers in case units. IMS DDD – Sales of drugs by the w.. Know More

What is fbp in pharma?

Answer: INTRODUCTION-  Fluid bed processing involves coating, granulation, drug layering and drying of particulate material. GEA supplies fluid bed processors for blending, granulating, drying, pelletizing and coating applications in the pharmaceutical industry. FBE Series is a world-class range of fluid b.. Know More

What is osd in pharma?

Answer: Within the pharmaceutical industry, secondary manufacturing of oral solid dosage (OSD) forms has traditionally been a batch-oriented operation with some semi-continuous unit operations. Oral Solid Dosage (OSD) Drug facilities producing tablets and capsules use well defined unit operations, regardles.. Know More

What is quva pharma?

Answer: QuVa Pharma is a nationally recognized, FDA-registered, industry leader in the quality-compliant manufacturing of compounded, ready-to-administer sterile. QuVa Pharma is an employer of choice, leading the way in the 503B compounding industry. QuVa Pharma is a pharmaceutical company engaged in the in.. Know More

What is nme in pharma?

Answer: A new molecular entity (NME) is a drug that contains an active moiety that has never been approved by the FDA or marketed in the US. A form of normal phase chromatography that is used for the analysis and purification of low to moderate molecular weight, thermally labile. Under FD&C 505(c)(3)(D) and.. Know More

What is gcp in pharma?

Answer: Good Clinical Practice (GCP) is an international ethical and scientific quality standard for the design, conduct, performance, monitoring, auditing, recording, analyses and reporting of clinical trials. Pharma IQ - Glossary - Good Clinical Practice (GCP). Good clinical practice (GCP) is an internati.. Know More

What is rmg in pharma?

Answer: Rapid mixer granulator is used for granulation in pharmaceutical manufacturing. Working and principle of Rapid Mixer Granulator (RMG) · Impellers: Impellers are fixed at the bottom of dome shaped stainless steel bowl. RMG consists of Mixing chamber , Impeller , Chopper ,Discharge port , Filter assem.. Know More

What is qa in pharma?

Answer: Quality Assurance (QA) covers all aspects that could have an impact on the quality of prescribed pharmaceutical products. In the pharmaceutical industry, quality assurance (QA) is essential for ensuring that pharmaceutical products are manufactured to a safe and consistent standard. Quality assuranc.. Know More

What is amv in pharma?

Answer: Analytical Test Method Validation (AMV) of Finished Pharmaceutical Products (FPP) & system suitability requirements. Also see: Analytical Method Validation Definitions in Pharmaceuticals. Defination of Analytical Method Validation components as Accuracy, Precision, Specificity, Detection Limit, Quan.. Know More

What is fdf in pharma?

Answer: FDF stands for finished dosage form. Almost 20 years of experience in supplying finished dosage forms (FDF) to third parties makes Polpharma a reliable partner as it anticipates its. As stated previously, FDF stands for finished dosage form, and it refers to the actual finalized drug product that is.. Know More

What is laf in pharma?

Answer: LAF which is linear and positive up to working surfaces and thus prevents contamination. Standard operating procedure of Laminar air flow unit installed in sampling room. Standard operating procedure of LAF chamber unit cleaning, filter cleaning and frequency of cleaning and calibration that is used.. Know More

What is aql in pharma?

Answer: Acceptable Quality Level is a sampling plan according to the batch size and inspection levels. This classifies the defects obtained in uncoated / coated tablets and filled capsule by visual inspection of samples as per AQL (Acceptable Quality Level) to decide. AQL' stands for 'Acceptance Quality Lim.. Know More