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

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As much of the content of this draft guidance for cellular and gene therapy (CGT) products is articulated elsewhere, this document serves as a one-stop shop or Cliffs Notes for the numerous guidance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

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

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

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

pharmaphorum

JANUARY 12, 2022

The cobas pulse system is a point-of-care device that combines a glucose test strip reader with a touch screen that is used for displaying patient information and data, as well as analysing and sharing clinical results.

Hospitals 128

Hospitals Packaging Documentation 128

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

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

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

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

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

FDA Law Blog: Biosimilars

SEPTEMBER 24, 2024

The NDRP focused on six strategic objectives one of which was the implementation of the Integrated Assessment which per CDER was designed to “critically, collaboratively, and consistently assess whether information in drug approval applications meets legal and regulatory requirements.” 89 FR 74966 at 74968 (Sept.

Documentation 59

Documentation Packaging 59

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

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

Pharmaceutical Technology

JULY 15, 2022

In a budget change proposed in February and confirmed in May , California’s Department of Health Care Access and Information (HCAI) requested a one-time investment of $100 million for Newsom’s CalRx Biosimilar Insulin initiative. The state plans to work directly with a contract manufacturing organization (CMO) to manufacture low-cost insulin.

Biosimilars 131

Biosimilars Diabetes Documentation Packaging 131

FDA Law Blog: Biosimilars

JULY 10, 2023

After a firm submits a 510(k) to FDA, FDA will request still more information after a first-pass review. According to the 2 nd Quarter FY2023 MDUFA V Performance Report , FDA issued a request for additional information (AI request) on the first FDA review cycle for 63% to 68% of 510(k)s submitted in FY2018 to FY2022.

Documentation 75

Documentation Packaging Communication Labelling 75

European Pharmaceutical Review

JANUARY 25, 2024

Within the EU, patient information leaflets (PILs) are not merely a regulatory requirement but a cornerstone of patient safety. These standardised documents provide meticulously curated and scientifically approved information. 11 This requirement directly contradicts what is included in Article 63.

Packaging 98

Packaging Documentation Communication Pharmaceutical Companies 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

Express Pharma

APRIL 6, 2023

As a result, nutraceutical startups need to stay informed about the latest regulatory changes and requirements in the states where they do business. To achieve this, startups should implement rigorous quality control measures throughout their production processes, from sourcing ingredients to manufacturing and packaging.

Labelling 98

Labelling Dosage Packaging Documentation 98

GMPSOP

MAY 26, 2023

Imagine your company is going to install new information management software in the laboratory to replace the old one. The keywords in any change control management process are compliance with regulatory requirements, impact assessment, change verification, and maintain documentation. Additional documents included each month.

Documentation 52

Documentation Packaging Communication Customer Service 52

GMPSOP

MAY 26, 2023

Imagine your company is going to install new information management software in the laboratory to replace the old one. The keywords in any change control management process are compliance with regulatory requirements, impact assessment, change verification, and maintaining documentation. Additional documents included each month.

Documentation 52

Documentation Packaging Communication Customer Service 52

Pharma in Brief

MARCH 18, 2021

Health Canada is seeking input from industry stakeholders on a new draft guidance document that discusses the use of electronic media in prescription drug labelling. Consultation on the draft guidance document is open until May 7, 2021. Any non-drug information must be derived from trusted, high-quality sources.

Labelling 40

Labelling Documentation Packaging 40

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

Express Pharma

MARCH 16, 2025

and Europe held manufacturers accountable for their environmental impact, leading to an increase in partnerships with tech companies focused on sustainable packaging and production solutions. For patient-centric innovations to succeed, patients must be informed about their options and the benefits of personalised treatments.

Biosimilars 110

Biosimilars Insurance Coverage and Processing Pharmaceutical Companies Pharmaceutical Companies 110

Pharmaceutical Technology

MAY 17, 2023

Marketing Packages Taking part in the Excellence Awards offer your company many benefits including being able to tell the market, new and prospective clients about your achievement. For full details on the benefits, the scale of our audience and the marketing packages on offer please download the RESEARCH GUIDE.

Packaging 52

Packaging Documentation 52

National Association of Boards of Pharmacy

OCTOBER 23, 2024

The exemption applies to “any … eligible trading partners, which … have successfully completed or made documented efforts to complete data connections with their immediate trading partners.” Know where your current product transaction information is being stored and how to access it.

Packaging 50

Packaging Documentation Pharmacy Technician 50

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

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. 240 SOPs, 197 GMP Manuals, 64 Templates, 30 Training modules, 167 Forms.

Documentation 59

Documentation Packaging Communication Pharmaceutical Companies 59

Quality Matters

NOVEMBER 5, 2024

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.

Pharmaceutical Manufacturing 78

Pharmaceutical Manufacturing Packaging Documentation 78

Pharmaceutical Technology

JUNE 19, 2023

Issues with regulatory requirements and documentation can also cause significant delays, while any inaccuracies in translations on labelling can mean that dosage and storage information is not correctly understood or followed. The facility features multiple pack rooms and full 24-hour temperature monitoring capabilities.

Labelling 52

Labelling Packaging Documentation Dosage 52

Syner-G

SEPTEMBER 28, 2023

There are common, though preventable, pitfalls that applicants may encounter, including incomplete or inadequate nonclinical data, which can be addressed by ensuring that the package of nonclinical studies submitted in the application adhere to applicable ICH and FDA guidelines.

Documentation 59

Documentation Drug Development Packaging 59

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

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

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

GMPSOP

SEPTEMBER 22, 2022

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. To come to a methodical conclusion, the sampling inspector has to know the following information.

Packaging 52

Packaging Documentation Labelling 52

Pharmaceutical Technology

SEPTEMBER 20, 2022

The information contained within the download document is intended for pharmaceutical manufacturers, wholesalers, retailers and distributors, pharmaceutical executives, medical representatives, business development managers, retail salesmen, sales managers, pharmacy executives, and any other individual involved in pharmaceutical marketing.

Documentation 40

Documentation Pharmaceutical Manufacturing Packaging Pharmaceutical Companies 40

FDA Law Blog: Biosimilars

MARCH 27, 2023

Such codes need to be placed on device labels and packages to allow devices to be easily identified and tracked throughout their lifecycle, except where the rule provided for an exception or alternative. In addition, the final rule requires the submission of product information to the Global Unique Device Identification Data (GUDID).

Labelling 45

Labelling Packaging Documentation 45