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

RX Note

JULY 29, 2023

In fact, off-label drug uses can become widely entrenched in clinical practice and become predominant treatments for a given clinical condition. In a study published in JAMA Internal Medicine , off-label use lacking strong scientific evidence had a higher adverse drug event rate compared with on-label use.

Labelling 40

Labelling Dosage Immunity Immunization 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

European Pharmaceutical Review

JULY 4, 2023

The document contains requirements and guidance for testing for bacterial endotoxins. This includes products that must be non-pyrogenic based on either intended use or non-pyrogenic label claim, or both. This document relating to microbiological methods is based on ANSI/AAMI ST72. Why is bacterial endotoxin testing important?

Documentation 111

Documentation Labelling 111

pharmaphorum

SEPTEMBER 2, 2020

The guidance published on the Medicines and Healthcare products Regulatory Agency (MHRA) website is broadly similar to arrangements laid out in a Brexit “no deal” document published last year.

Documentation 124

Documentation Labelling 124

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Health Canada is seeking input from industry stakeholders on a new draft guidance document that discusses the use of electronic media in prescription drug labelling. Consultation on the draft guidance document is open until May 7, 2021. Guidelines for electronic labelling. Background and scope.

Labelling 40

Labelling Documentation Packaging 40

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. And accurate labelling and translation are critical for this sector.

Labelling 52

Labelling Packaging Documentation Dosage 52

pharmaphorum

MAY 25, 2022

Here, we take a look at the top five takeaways from the document: 1. Companies should still clearly document their reasons for supporting events, including virtual and hybrid international congresses, said the document. Identifying the appropriate code and label. The codes still apply. End of the host country.

Documentation 105

Documentation Communication Pharmaceutical Manufacturing Labelling 105

pharmaphorum

JUNE 8, 2022

The new tool works as a component of Apple’s Health app and will let users add drugs or other health products like vitamins and supplements to a personal list – either by scanning a label or finding the product in a directory – and create custom schedules for them.

Documentation 131

Documentation Labelling 131

pharmaphorum

OCTOBER 6, 2020

Apply Data: Regulatory employees should be using stored data to intelligently create submission documents. By limiting documents full of free text fields and subjectivity companies can adopt a more digitised approach, where document templates can be compiled automatically from available data. Label Authoring and Tracking.

Documentation 114

Documentation Communication Labelling Data Entry 114

Express Pharma

FEBRUARY 13, 2024

Features of the new FedEx Life Science Center include: · Covers all three temperature-controlled zones o Controlled Ambient (15°C to 25°C) o Refrigerated (2°C to 8°C) o Frozen -20°C and Deep Frozen -80°C · 24/7 monitoring and alarms for immediate response and intervention. · Destruction services for returned Investigational (..)

Packaging 96

Packaging Documentation Labelling 96

Express Pharma

FEBRUARY 12, 2025

“It is not justifiable to compare pharma products, where a lot of work has already been done and well-documented with international harmonisation (e.g., He stresses the need for a collaborative effort between industry players and regulatory bodies to establish clear guidelines that ensure the safety and efficacy of products.

Documentation 99

Documentation Labelling 99

Putting Patients First Blog

APRIL 8, 2025

9 Labeling materials should describe how the technology works, its intended use, known limitations, and the circumstances under which human oversight is recommended. 54 ,55 If significant differences appear across subgroups, sponsors should address them prior to regulatory approval or disclose any remaining limitations in the device labeling.

Documentation 52

Documentation Labelling Communication 52

Express Pharma

APRIL 6, 2023

This can include everything from product testing and labelling to marketing and advertising requirements. Challenge 4: Quality control and safety concerns Nutraceutical startups must ensure that their products meet quality and safety standards, as well as comply with labelling and advertising regulations.

Labelling 98

Labelling Dosage Packaging Documentation 98

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

Community Pharmacy

JULY 31, 2023

It is best practice to carry these in a bottle with a prescription label. Bring Prescriptions & Notes (especially abroad) When traveling, it’s important to maintain a steady prescribed medication intake routine and have all your documentation on hand to avoid complications.

Community Pharmacies 96

Community Pharmacies Documentation Labelling 96

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

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. Additional documents included each month. ensure traceability and compliance.

Packaging 52

Packaging Documentation Labelling Dosage 52

FDA Law Blog: Biosimilars

APRIL 25, 2023

The primary vehicle for FDA to request cybersecurity information in premarket submissions has been guidance documents. Through a recent (and very short) Guidance document, FDA indicated that, starting on October 1, 2023, FDA may base “refuse to accept” (RTA) decisions on the information required by section 524B. Loose Ends IDEs.

Documentation 105

Documentation Labelling Communication 105

Pharmaceutical Technology

OCTOBER 31, 2022

Outlook Therapeutics president and CEO Russell Trenary said: “This BLA acceptance and PDUFA date are significant milestones in our mission to offer clinicians and their patients the first and only on-label, ophthalmic bevacizumab to treat wet AMD. “If

Labelling 59

Labelling Compounding Pharmacies Compounding Documentation 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

Pharma Pathway

JANUARY 26, 2023

Intermediate Job Description: To work in Pharma area, activities i.e. packing, sealing, labelling Documents to Carry: ID Proofs: Aadhar Card, Pan Card Photocopies of All Education Qualification Certificates Walk-In Date: 28th Jan’ 2023 Time: 9:30 AM to 12:30 PM Venue: Rakshit Pharmaceuticals Ltd, Plot No.

Documentation 52

Documentation Labelling 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

Express Pharma

JUNE 2, 2023

By accurately documenting the movement of drugs, manufacturers can identify any quality issues that may arise during production, storage, or transportation. Quality control and regulatory compliance: Traceability is crucial for maintaining quality control and ensuring compliance with stringent regulations in the medicine space.

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Adverse Reactions Packaging Documentation Dosage 103

Pharmacy Joe

MAY 1, 2024

Subscribe on iTunes , Android , or Stitcher The label of “penicillin allergic” usually sticks to a patient’s medical record forever. The documented allergy was severe in nature for 13% of patients, moderate for 43%, and unknown for 44%.

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Inpatient Medical Records Documentation Labelling 98

Big Molecule Watch

MAY 3, 2024

The guidance remains in draft form and, as with any FDA guidance document, it is not legally binding and, when final, will reflect FDA’s “current thinking” on this topic.

Biosimilars 49

Biosimilars Communication Labelling Documentation 49

Express Pharma

JANUARY 2, 2025

The drugs, labelled as being manufactured in various countries including Ireland, Turkey, the USA, and Bangladesh, were found without any supporting documents to prove their legitimate importation into India. In the absence of such documentation, these drugs are deemed to be spurious.

Documentation 52

Documentation Labelling Diabetes 52

FDA Law Blog: Biosimilars

JUNE 27, 2023

FDA also requests a “detailed description of the allegation with any available supporting documentation.” In our experience, the more detailed the documentation that accompanies the submission, the more likely FDA will follow-up on the submission. We hope the status is more than just an “Under Review” label.

Documentation 59

Documentation Labelling 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

Pharma Marketing Network

MARCH 18, 2025

Avoiding misleading claims or unapproved off-label promotions. Keep Detailed Records of PPC Campaigns Document ad approvals, compliance reviews, and campaign changes to maintain transparency in case of audits. Best practices include: Clearly stating the drug name, indications, and fair balance information.

Pharmaceutical Companies 52

Pharmaceutical Companies Pharmaceutical Companies Documentation Labelling 52

GMPSOP

JUNE 9, 2024

Additional documents included each month. employee assay qualification) must be documented in an SOP for each assay the lab performs with pre-determined acceptance criteria. employee assay qualification) must be documented in an SOP for each assay the lab performs with pre-determined acceptance criteria. gown qualification).

Method Validation 52

Method Validation Documentation Health and Personal Care Stores Labelling 52

pharmaphorum

JUNE 16, 2021

Aside from the lack of evidence that Aduhelm (aducanumab) provides any meaningful clinical benefit is “the fact that the drug has a well-documented risk of potentially serious brain injury,” wrote Carome in the letter.

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Documentation Labelling 92

FDA Law Blog: Biosimilars

MAY 8, 2023

a) , and related guidance documents (e.g., Post-market, manufacturers can make modifications consistent with the PCCP and document the modification in accordance with their quality system, without the need for a new marketing submission. See 21 CFR 807.81(a)(3) a)(3) and 21 CFR 814.39(a)

Documentation 98

Documentation Labelling 98

FDA Law Blog: Biosimilars

APRIL 19, 2023

The new draft guidance continues to borrow heavily from the NDA process and FDA notes that it used the same source material on which other drug application recommendations are based including the Common Technical Document (CTD). x 11-inch paper, and with hyperlinks to references and numbered pages.

Documentation 59

Documentation Labelling 59

pharmaphorum

DECEMBER 30, 2022

The report also finds that the joint briefing document presented to the advisory committee did not adequately represent differing views within the FDA on Aduhelm. Biogen’s hopes were for sales of around $18 billion per year from Aduhelm, says the document, without consideration of the impact that could have on the US healthcare system.

Documentation 59

Documentation Labelling 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. Clinical trial packaging and labelling solutions. Trends in clinical packaging.

Packaging 40

Packaging Labelling Pharmaceutical Companies 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. The compliance dates were first published in 2013, and subsequently updated in various guidance documents and regulations published by FDA.

Labelling 45

Labelling Packaging Documentation 45