European Pharmaceutical Review

NOVEMBER 24, 2022

One area in which the problem can be tackled effectively is product packaging. With predictions that the global market for anticounterfeiting packaging is set to reach almost $250 billion by 2026, growth in authentication and anti-tamper devices such as holograms appear to have a healthy future.”

Packaging 111

Packaging Labelling Documentation Dosage 111

pharmaphorum

JANUARY 12, 2022

Those packages include S4DX’ Satellite app for sample management, imito’s medical image and documentation handling software, decide’s GlucoTab insulin dosing tool, CardioSignal for monitoring cardiac rhythms, and SteadySense’s continuous temperature measurement tool SteadyTemp.

Hospitals 128

Hospitals Packaging Documentation 128

European Pharmaceutical Review

SEPTEMBER 2, 2022

The sampling strategy must be supported by sound and properly cited sources whose conclusions must be presented as supportive elements in the study documents. The following four elements of sampling methodology were found to be under-documented in RMM effectiveness studies: Supporting documentation for country/region selection.

Adverse Reactions 96

Adverse Reactions Documentation Medical Schools Packaging 96

GMPSOP

AUGUST 11, 2024

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.

Packaging 52

Packaging Documentation Labelling Dosage 52

European Pharmaceutical Review

OCTOBER 3, 2024

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?

Packaging 52

Packaging Pharmaceutical Companies Pharmaceutical Companies Pharmaceutical Manufacturing 52

European Pharmaceutical Review

JULY 5, 2023

The long-awaited PDA TR 43 report provides an approach to a quality decision-making process and represents best practices for the identification and classification of visual nonconformities for (empty) glass containers as pharmaceutical product packaging.

Pharmaceutical Manufacturing 96

Pharmaceutical Manufacturing Packaging Documentation Pharmaceutical Companies 96

GMPSOP

DECEMBER 10, 2023

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.

Packaging 40

Packaging Health and Personal Care Stores Labelling Documentation 40

Pharmaceutical Technology

SEPTEMBER 15, 2022

Packaging plays a vital role in maintaining the quality, safety, user-friendliness and marketability of drugs and other pharmaceutical products. Finding the best commercial packaging suppliers in contract marketing. Pharmaceutical packaging formats and materials. Pharmaceutical packaging formats and materials.

Packaging 40

Packaging Labelling Pharmaceutical Manufacturing Documentation 40

Pharmaceutical Technology

SEPTEMBER 20, 2022

Clinical packaging and labelling follow stringently controlled procedures and high-standard quality control measures to assure the safety and functionality of investigational medicinal products, during their storage, distribution, and use. Finding the best clinical trial packaging services providers. Trends in clinical packaging.

Packaging 40

Packaging Labelling Pharmaceutical Companies Pharmaceutical Companies 40

pharmaphorum

JUNE 18, 2021

UK company MIOTIFY has developed a web-based software platform that product teams can use to configure medical algorithms quickly, create code packages to harness them and generate supporting documentation – all in a format that is designed to meet regulatory requirements for software as a medical device (SaMD). Sheena Macpherson.

Documentation 98

Documentation Packaging Diabetes 98

European Pharmaceutical Review

DECEMBER 19, 2023

The document was adopted by EMA’s Management Board at its December meeting. AI-supported spectroscopy delivers superior pharmaceutical packaging QC The post European regulators prepare for AI in pharma appeared first on European Pharmaceutical Review.

Packaging 105

Packaging Documentation 105

GMPSOP

MARCH 25, 2024

manufacturing, packaging, testing, storage and/or distribution of products) shall be validated to provide assurance that their system is capable of producing without error and that the results are robust and reproducible.” Additional documents included each month. – Documented Source Code. Checkout sample preview s.

Documentation 59

Documentation Packaging Communication Pharmaceutical Companies 59

Express Pharma

JUNE 2, 2023

As part of these efforts, the government has implemented regulations mandating API (active pharmaceutical ingredient) manufacturers and pharma brands to incorporate barcoding on product packaging. This regulatory step is aimed at preventing falsified medicines from entering the market.

Adverse Reactions 103

Adverse Reactions Packaging Documentation Dosage 103

Pharma Pathway

JANUARY 10, 2023

M.Tech / Diploma with 0-10 years of experience in below mentioned skill sets: For Biocon BHD: DP Packaging. Required Documents: Resume. Skill Required: If you are M.Sc/ B.Sc / M.Pharm/ B.Pharm/ BE/ B.Tech/ M.E/ DP Filling & Formulations. DP Downstream Manufacturing. DS Upstream Manufacturing. DS Process Engineering & MSAT.

Packaging 67

Packaging Documentation 67

FDA Law Blog: Biosimilars

SEPTEMBER 24, 2024

These efforts included the adoption of a new review template for the assessment and documentation to be used in reviewing NDAs and BLAs with an overall goal of having a more collaborative inter-disciplinary approach to the process. There are those who are willing to read through the more extensive package consisting of all the reviews.

Documentation 59

Documentation Packaging 59

GMPSOP

MARCH 30, 2024

Line clearance ensures the processing line is free of any irrelevant products, components, and documentation that could be left accidentally from an earlier batch. Line opening ensures correct products, components, and documentation are brought into the processing line so the operation can commence without error.

Labelling 52

Labelling Packaging Documentation Pharmaceutical Manufacturing 52

GMPSOP

MAY 31, 2024

A validation master plan (VMP) is a strategic document that identifies the elements to validate, the approach to each element, organizational responsibilities, and a strategy for maintaining validation documentation. – General guidance for validation document format. Additional documents included each month.

Documentation 59

Documentation Method Validation Pharmaceutical Companies Pharmaceutical Companies 59

GMPSOP

MAY 26, 2023

The keywords in any change control management process are compliance with regulatory requirements, impact assessment, change verification, and maintain documentation. All documentation must be kept as supporting evidence. Additional documents included each month. Additional documents included each month. Subscribe a.

Documentation 52

Documentation Packaging Communication Customer Service 52

GMPSOP

MAY 26, 2023

The keywords in any change control management process are compliance with regulatory requirements, impact assessment, change verification, and maintaining documentation. All documentation must be kept as supporting evidence. Additional documents included each month. Additional documents included each month. Subscribe a.

Documentation 52

Documentation Packaging Communication Customer Service 52

GMPSOP

FEBRUARY 28, 2024

Regulatory requirements for cleaning and sanitation in pharmaceuticals For more than a few decades, it has been an essential GMP requirement that all cleaning and sanitation steps in a pharmaceutical plant be documented accurately and validated to prove they work. Additional documents included each month. Checkout sample preview s.

Documentation 98

Documentation Packaging Pharmaceutical Manufacturing Compounding 98

Pharmaceutical Technology

SEPTEMBER 5, 2022

The document contains detailed information on the suppliers and their product offerings, alongside contact details to aid your purchasing or hiring decision. Quality in terms of number of defective items, packaging and labelling, quality management system certification, research, development, and innovation.

Documentation 52

Documentation Packaging Labelling Pharmaceutical Manufacturing 52

GMPSOP

OCTOBER 26, 2022

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.

Documentation 52

Documentation Method Validation Packaging Pharmaceutical Companies 52

Pharmacy Joe

OCTOBER 25, 2023

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.

Dosage 111

Dosage Inpatient Packaging Documentation 111

Express Pharma

JUNE 5, 2024

The enduring harmful effects of these substances on human health are well-documented, leading to regulatory controls in numerous countries. Other strategies can be waste minimisation, green packaging, energy efficiency and sustainable sourcing. Discharging antibiotics can promote antibiotic-resistant pathogens.

Pharmaceutical Manufacturing 98

Pharmaceutical Manufacturing Packaging Documentation Compounding 98

Pharma Pathway

JANUARY 10, 2023

M.Tech / Diploma with 0-10 years of experience in below mentioned skill sets: For Biocon BHD: DP Packaging. Required Documents: Resume. Skill Required: If you are M.Sc/ B.Sc / M.Pharm/ B.Pharm/ BE/ B.Tech/ M.E/ DP Filling & Formulations. DP Downstream Manufacturing. DS Upstream Manufacturing. DS Process Engineering & MSAT.

Packaging 52

Packaging Documentation 52

Pharma Pathway

JANUARY 10, 2023

M.Tech / Diploma with 0-10 years of experience in below mentioned skill sets: For Biocon BHD: DP Packaging. Required Documents: Resume. Skill Required: If you are M.Sc/ B.Sc / M.Pharm/ B.Pharm/ BE/ B.Tech/ M.E/ DP Filling & Formulations. DP Downstream Manufacturing. DS Upstream Manufacturing. DS Process Engineering & MSAT.

Packaging 52

Packaging Documentation 52

GMPSOP

MARCH 3, 2024

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?

Health and Personal Care Stores 52

Health and Personal Care Stores Packaging Labelling Documentation 52

Quality Matters

NOVEMBER 27, 2023

General Chapters mentioned in the draft guidance Visible particulate matter: USP General Chapter was introduced to address the absence of documents outlining quality test requirements for ophthalmic products and became recognized in USP39. Learn more in a complimentary course “ USP Certificate of Document and Reference Standards.”

Documentation 52

Documentation Packaging Dosage 52

pharmaphorum

AUGUST 16, 2021

Thankfully, paper-based studies are becoming a thing of the past, but spreadsheets and Word documents are still commonly used to design and build trials. These are now used by several regulatory bodies, including the Food and Drug Administration (FDA) and the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) for submission packages.

Documentation 98

Documentation Vaccines Packaging Pharmaceutical Companies 98

FDA Law Blog: Biosimilars

FEBRUARY 21, 2024

This amendment marks the first significant revision of Part 820 since 1996, which established the Quality System (QS) regulation and “included requirements related to the methods used in, and the facilities and controls used for, designing, manufacturing, packaging, labeling, storing, installing, and servicing of devices intended for human use.”

Labelling 59

Labelling Packaging Documentation 59

GMPSOP

JULY 23, 2023

Installation qualification will provide you with documented evidence that the equipment or system has been designed, developed, supplied, and installed in accordance with design drawings, the supplier’s recommendations, and in-house user requirements. Additional documents included each month. Checkout sample preview s.

Documentation 52

Documentation Method Validation Packaging Labelling 52

FDA Law Blog: Biosimilars

DECEMBER 6, 2024

As much of the content of this draft guidance for cellular and gene therapy (CGT) products is articulated elsewhere, this document serves as a one-stop shop or Cliffs Notes for the numerous guidance documents now covering CGT product development. CBER will not commit to reviewing packages greater than 250 pages.

Documentation 59

Documentation Packaging Clinical Pharmacology Drug Development 59

GMPSOP

NOVEMBER 19, 2023

Additional documents included each month. If significant trends are identified, they should be documented, and changes should be made to avoid out-of-specification results. The number of batches manufactured, released and rejected should be documented. 240 SOPs, 197 GMP Manuals, 64 Templates, 30 Training modules, 167 Forms.

Documentation 52

Documentation Packaging Method Validation Process Improvement 52

pharmaphorum

FEBRUARY 10, 2021

It will also produce policy documents and information packages for patients, doctors and senior management in companies, Other workstreams could include computational strategies to make such simulations more powerful and efficient, new curricula to educate the workforce on the development and use of the technologies.

Drug Development 76

Drug Development Packaging Documentation Hospitals 76

FDA Law Blog: Biosimilars

JULY 10, 2023

In this case, the FDA clock start date is determined as the date of receiving the submission by the Document Control Center (DCC). When referencing documents within the AI response, cite location within the 510(k) supplement (e.g., Attachment number) and document name or description as appropriate.

Documentation 75

Documentation Packaging Communication Labelling 75

Express Pharma

OCTOBER 4, 2023

Another concern for smaller players is that the updated Schedule M will bring in mandatory annual audits of their approved suppliers, including raw material and packaging material suppliers. However, annual audits would add to the documentation and administrative cost of doing business, especially painful for the MSME sector.

Packaging 103

Packaging Documentation 103

Express Pharma

SEPTEMBER 19, 2024

These three co-located trade fairs bring together a wide array of technologies under one roof, covering the entire spectrum of laboratory technology, life sciences, pharmaceuticals, and packaging.  There will be case study presentations on CAPA, precision lighting, ergonomic seating in classrooms, and building operational excellence.

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Packaging Documentation 105