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I'm talking about Good Manufacturing Practice (GMP), a set of guidelines that govern the production, testing, and packaging of generic drugs. Documentation and record-keeping : Manufacturers must maintain accurate and detailed records of their manufacturing processes, including batch records, quality control records, and training records.
Indeed, a key aspect of EU GMP Annex 1 is the requirement for pharmaceutical manufacturers to develop a comprehensive Contamination Control Strategy (CCS) that documents their approach to assuring the sterile drug product’s high quality and, therefore, enhancing patient safety. Register your details to read more The post How ready are you?
In this article, we delve into the highlights of the Chandigarh Pharma Summit 2023, and showcase the key takeaways and insights from the presentations and discussions at the event. Embracing innovation in pharma packaging is vital become future Shivaji Chakraborty, Asst.
Given that multiple work packages may often start or end together, or else take longer than others ( Figure 1 ), the introduction of new PAT requires assessment and planning by multiple departments. Any documentation, such as validation reports then helps with compliance and later regulatory submissions and requests.
Subscribe on iTunes , Android , or Stitcher If you navigate to the page on the website for the Institute for Safe Medication Practices that once hosted the document titled “Oral Dosage Forms That Should Not Be Crushed” you will instead find a notice that the list has been removed from the ISMP website.
To maintain the integrity and safety of these investigational products, you must adhere to Good Manufacturing Practice (GMP), FDA Clinical Trail Guidance Documents , and relevant ISO or EN standards. Additional documents included each month. Compliance with EN 46001 and 21 CFR 820 is essential for medical devices.
This article explores the potential impact of the proposal and considers how manufacturers can ensure the safety and reliability of their products. billion Global concerns surrounding PFAS, or per- and polyfluoroalkyl substances, are due to their well-documented effects on human health and the environment.
This article explores just one aspect of the RMP, that of RMMs, and how their effectiveness is measured with Dr Sophie Jouaville, an associate principal at IQVIA working on the design and oversight of non-interventional real-world evidence (RWE) safety and health economics and outcomes research (HEOR) studies.
This article uncovers the hidden elements of market access success, revealing what it takes to move from FDA approval to formulary inclusion, provider buy-in, and patient adoption. A value document submitted to payers outlining clinical data, economic models, and patient impact to support formulary inclusion. What is an AMCP dossier?
These standardised documents provide meticulously curated and scientifically approved information. 11 This requirement directly contradicts what is included in Article 63. 11 This requirement directly contradicts what is included in Article 63. Article 63 EMA (29 January 2020).
The scope of this article applies to all regulated medicinal products manufactured at a GMP site that undergo annual product quality review. The content of this article does not supersede or replace any local or international regulatory requirements. Additional documents included each month. Checkout sample preview s.
According to cGMP, validation in pharmaceutical industry can be defined as “Establishing documented evidence which provides a high degree of assurance that a specific process will consistently produce a product meeting its pre-determined specifications and quality attributes.” Additional documents included each month.
This article can help you understand who is responsible for preparing the validation master plan, the stages of the validation life cycle, the risk-based prioritization of validation items, how to prepare a validation schedule, and some practical examples. – General guidance for validation document format. 12 or 24 months). .
Acceptable Quality Limit is used to make an informed decision whether to accept or reject an incoming packaging components lot by assessing the lot size and types of defects found during a pre-determined level of inspection. Additional documents included each month. All written and updated by GMP experts. Checkout sample preview s.
API DMFs are documents containing information on APIs that are submitted to the U.S. Food and Drug Administration (FDA) by API manufacturers to provide confidential, detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of human drug products.
If you are completely unfamiliar with what is installation qualification then we suggest you read the article Validation in Pharmaceutical Industry first. Installation qualification verifies and documents that all critical aspects of equipment installation adhere to predetermined specifications and manufacturer’s recommendations.
Additional documents included each month. Packaging/labeling/Misbranding: 41 warnings vi. Similarly, the packaging, labeling, and misbranding-related warning letters were the top reasons in 2019. Additional documents included each month. 240 SOPs, 197 GMP Manuals, 64 Templates, 30 Training modules, 167 Forms.
Subscribe on iTunes , Android , or Stitcher If you navigate to the page on the website for the Institute for Safe Medication Practices that once hosted the document titled “Oral Dosage Forms That Should Not Be Crushed” you will instead find a notice that the list has been removed from the ISMP website.
This article is to help all personnel maintain a state of alertness to make sure that the plant housekeeping is always kept at the peak of efficiency. They should place all discarded cardboard, paper, and corrugation from the Packaging Dept. Quality assurance inspectors destroy all unused labels and inserts from the Packaging Lines.
The analyst should ensure that the supervisor is notified as soon as an OOS event occurs, the sample is retained, and a documented investigation is commenced. – Document control records management and archiving systems. Additional documents included each month. You must document all sampling procedures and plans in use.
Starting materials are processed, sampled, tested, packaged, and released before the finished products are stacked on pharmacy shelves. Sampling is carried out on intermediate processed materials and tested to ensure those are formulated correctly, free from contamination and qualified for filling and packaging. as their visual aids.
Table of Contents If you are looking for literary help to write an actionable procedure on corrective and preventive action for your workplace or school, this article will be a good place to start. Additional documents included each month. The entire unused packaging lot which was quarantined was returned to the supplier.
In this article, we will briefly discuss some essential elements of analytical method transfer, industry best practices, method transfer strategies, method transfer process workflow, and necessary considerations for a seamless transition. Additional documents included each month. All written and updated by GMP experts. Subscribe b.
This article will focus on G(C)LP due to its significance in everyday laboratory operations. Additional documents included each month. The points below outline some areas in the codes where G(C)LP regulations are embedded in the GMP regulations and guidance documents. Additional documents included each month.
Gathering transaction information for recalls at the package level. Document the date and the number of relevant full-time equivalent employees (FTEs) for each parent company pharmacy. Conducting product verifications for suspect and illegitimate products. FDA recommends this be based on the November 2024 expected employee filings.
This article explores how to prevent chemical spills, respond to and manage spills, dispose of contaminated materials, report spills, and assign responsibilities to the spill response team. Additional documents included each month. Additional documents included each month. Additional documents included each month.
Two potential 340B developments for 2024 In an article dated January 5, the subscriber-only website 340B Report projected that “In 2024, congressional gridlock and election year dynamics will likely slow momentum on any comprehensive 340B program reform package.” If you’d like to read the ruling’s additional 19,209 words, Click Here.
Particularly the printed packaging materials where product information is presented. Printed packaging materials typically include product names, active ingredients, concentration, batch numbers, expiry dates, registration numbers, barcodes, etc. Commonly used packaging materials are cartons, inserts, leaflets, printed foil, etc.
While the document itself is a quarter of a century old at this point, it is laid out in such a way that relevancy is maintained. This guideline forms the key document referenced by regulatory authority documents that detail structural characterization requirements of biopharmaceuticals.
Cross contamination is dangerous in pharmaceutical industry as it can severely compromise patient safety if the content is not pure and the product package differs from what is written on the label. Additional documents included each month. What are the examples of cross contamination in pharmaceutical industry?
This article will explore the key considerations, best practices, and regulatory requirements for effective cleaning and sanitation that pharmaceutical companies must adhere to for optimal cleanliness and safety. Additional documents included each month. Additional documents included each month. Checkout sample preview s.
Stability testing ensures that the manufactured products remain safe, pure, and effective throughout their shelf life if they are kept in specified packaging and under environmental conditions. Additional documents included each month. 240 SOPs, 197 GMP Manuals, 64 Templates, 30 Training modules, 167 Forms. Checkout sample preview s.
Primary Packaging material designers. Secondary packagers. POST CONFERENCE WORKSHOP A: EU MDR 2017/745 Article 117 Requirements. Overview of the workshop: The workshop is aimed to provide an introduction to the key elements of the Medical Device Regulation that Companies affected by article 117 need to consider.
In this article, we will discuss important aspects of equipment cleaning that are required during pharmaceutical manufacturing. Equipment cleaning validation protocol was not discussed intensely in this article which was covered elsewhere in this blog. Additional documents included each month. Checkout sample preview s.
In the EU, the EU pharmaceutical package of reform 5 includes a proposed new Directive, 6 which will replace the current Medicines Directive (2001/83/EC). That proposed Directive contains a similar regulatory framework for decentralised manufacturing (see prospective Articles 142-153). But the UK framework will arrive first.
This article will explore the key considerations, best practices, and regulatory requirements for effective cleaning and sanitation that pharmaceutical companies must adhere to for optimal cleanliness and safety. Additional documents included each month. Additional documents included each month. Checkout sample preview s.
In this article, you will learn: How we are exposed to unhealthy air quality, indoors and outdoors. This article of mine discusses 19 thyroid-toxic products that have been banned by the FDA. Check out my article on mold toxicity to learn more about reducing mold in your home. (I How airborne toxins can affect the thyroid.
Beyond addressing proper documentation, storage, and transportation, GDPs incorporate appropriate mitigation strategies to control the foreseeable risks. An expanded rationale for the revision was included in a related Stimuli article. Also open for public comments is new General Chapter Qualification of Storage Areas.
In this article, the Pharma in Brief team has curated and provided updates on the most significant topics we covered in 2021. The Court noted that many of the documents excluded by the FC were not confidential and could be disclosed, and remitted the matter for redetermination on several issues (see here ). Introduction.
In this article, we will explore what operational qualification entails, its importance, and FDA requirements. These requirements mandate that pharmaceutical companies thoroughly document OQ protocols, testing methods, acceptance criteria, and results.
Step 4: Applying and integrating the evidence “ As clinicians, we need to be confident in our decision-making,” writes Shannon Casey in a recent Medpage article. Once clinicians have translated their research and skills into practice, they need to learn how to measure, quantify and document the outcomes data.
This article is crafted with real-life experiences and insights to help you fine-tune your material handling processes, optimize efficiency, and ensure compliance while working at the warehouse. It is important to assign in-house lot numbers for every container received next to the supplier’s lots of raw materials or packaging materials.
This article examines the various types of microorganisms commonly found in pharmaceutical production environments and explores the factors that influence their growth and survival. Additional documents are included each month. Additional documents are included each month. Additional documents are included each month.
Most of the time they want to pick my brain on where pharmacy is going or what could be possible, so with that being the case, I thought it would be better to put this article together that may help potentially interested parties. Even some of the most recent pitches are very similar to each other I feel. So let's get started!
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