European Pharmaceutical Review

JANUARY 25, 2024

This document is revised from a version published in October 2023. Firstly, leachables can compromise a products quality and therapeutic effect, by potentially interacting with the formulated drug product, the document reported. Moreover, manufacturers should document information about their safety thresholds, the guidance stated.

Documentation 98

Documentation Method Validation Packaging Labelling 98

GMPSOP

OCTOBER 16, 2022

Table of Contents Good documentation practice requires a system for control, implementation, maintenance and archival of GMP related documents and records. To implement good documentation practice and systems the site must assure that GMP documents and records are adequate, approved and in compliance with applicable GMP requirements.

Documentation 40

Documentation Data Entry Communication Packaging 40

European Pharmaceutical Review

AUGUST 23, 2022

Of the cGMP letters, three major types of violations – deficiencies in process validation, documentation practices (data integrity) and quality control – accounted for 26 percent, 21 percent and 15 percent of warning letters respectively. Overall, validation, documentation and quality control were the major cGMP violations.

Documentation 105

Documentation Pharmaceutical Manufacturing Packaging Labelling 105

FDA Law Blog: Biosimilars

FEBRUARY 2, 2025

The rules were implemented to enhance patient safety protections via revised drug handling, packaging, and delivery requirements. The rules include changes to the notification process, medication packaging, the handling of reports, and safety issues.

Packaging 59

Packaging Documentation Compounding 59

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As much of the content of this draft guidance for cellular and gene therapy (CGT) products is articulated elsewhere, this document serves as a one-stop shop or Cliffs Notes for the numerous guidance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

European Pharmaceutical Review

APRIL 8, 2025

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.

Documentation 52

Documentation Packaging Pharmaceutical Manufacturing 52

Pharma Pathway

FEBRUARY 22, 2023

-Apply Now @ Bharat Parenterals Limited Department : Regulatory Affairs Qualification: M.Pharm Designation: Officer/ Officer/ Executive/ Senior Executive Experience: 02 to 05 years (Freshers can also Apply) Job Responsibilities: Responsible for Dossier & Documents preparation. Review of the dossiers, DMF & Technical documents.

Documentation 73

Documentation Packaging Pharmaceutical Companies Pharmaceutical Companies 73

Pharmaceutical Technology

APRIL 26, 2023

Packaging plays a critical part in the pharmaceuticals and medical devices industries and is developed with its own set of security standards for the safety of consumers. The role of primary packaging has extended beyond the primary objectives of sterility, physical and chemical protection, and security.

Packaging 52

Packaging Documentation Communication Labelling 52

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

Express Pharma

DECEMBER 11, 2023

Proper documentation and effective data management were underscored as essential elements in building and sustaining a culture of quality and compliance within the industry. Embracing innovation in pharma packaging is vital become future Shivaji Chakraborty, Asst.

Packaging 104

Packaging Communication Documentation 104

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

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

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

EMCrit Project

JUNE 16, 2025

Intubated patients in the ED should have soft, wrist restraints places without the need for arduous, high-risk documentation or sitters Intubation Checklist EMCrit 176 – Updated EMCrit Rapid Sequence Intubation Checklist Awareness during Paralysis EMCrit 331 – Awareness after Resus RSI and ICU Paralysis – It is Unacceptable!!!

Labelling 110

Labelling Hospitals Packaging Documentation 110

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

Express Pharma

FEBRUARY 13, 2024

The post FedEx Life Science Center launched in Mumbai appeared first on Express Pharma.

Packaging 96

Packaging Documentation Labelling 96

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

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

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

Pharmaceutical Technology

JULY 15, 2022

The documents state that a partnership with a CMO would be cheaper than the state directly manufacturing insulin. California’s budget documents give few details about the tender process, but state that CalRx will spend $50 million to partner with a contract manufacturer to develop biosimilar insulin products in vial and pen form.

Biosimilars 131

Biosimilars Diabetes Documentation Packaging 131

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 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

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

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

European Pharmaceutical Review

APRIL 10, 2025

billion Global concerns surrounding PFAS, or per- and polyfluoroalkyl substances, are due to their well-documented effects on human health and the environment. However, given that PFAS are ubiquitous in the environment from stain-resistant carpets and non-stick pans, to packaging and electronics, to name a few the task is not that simple.

Pharmaceutical Manufacturing 59

Pharmaceutical Manufacturing Packaging Documentation Communication 59

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

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

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

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

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