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.

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Documentation Packaging Diabetes 98

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

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

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.

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FDA Law Blog: Biosimilars

JULY 10, 2023

We will then present an effective strategy to address FDA’s AI request in a timely manner. However, the strategy of addressing the AI request presented in the next section of this blog post applies to all three types of 510(k)s. Table 1 below shows the 510(k) submission process based on the MDUFA III Performance Goals.

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Documentation Packaging Communication Labelling 75

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

OCTOBER 4, 2023

The comparison between the existing Schedule M and the draft upgraded version (as outlined in the presentation given by Dr Eswara Reddy, JDCI, CDSCO at one of these webinars) would require considerable expenditure and time. These workshops are set to continue over the next few months.

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Packaging Documentation 103

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.

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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.

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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.

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Documentation Packaging Pharmaceutical Manufacturing Compounding 98

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

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. Additional documents included each month. All written and updated by GMP experts. Checkout sample preview s.

Packaging 52

Packaging Documentation Labelling 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.

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Documentation Method Validation Pharmaceutical Companies Pharmaceutical Companies 59

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. Background and scope. The draft guidance is based on Health Canada’s existing legal framework.

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Labelling Documentation Packaging 40

FDA Law Blog: Biosimilars

SEPTEMBER 27, 2023

The biggest changes are the addition of Type D and Initial Targeted Engagement for Regulatory Advice on CDER and CBER ProducTs (INTERACT) meetings to the four types already present (Types A, B, B (end of phase), and C), and the addition of additional meeting formats.

Packaging 64

Packaging Drug Development Documentation 64

GMPSOP

NOVEMBER 15, 2024

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.

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Packaging Dosage Documentation Labelling 59

Pharmaceutical Technology

MARCH 30, 2023

On the same day, researchers presented new interim data from the Phase III RUBY trial of GSK’s PD-1 antibody Jemperli (dostarlimab) in patients with primary advanced or recurrent endometrial cancer. Broadening uses and secured full approvals Since its first approval in September 2014, Keytruda has achieved blockbuster status on the market.

Chemotherapy 52

Chemotherapy Packaging Documentation 52

GMPSOP

OCTOBER 28, 2023

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.

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Documentation Method Validation Packaging Data Entry 52

RX Note

JUNE 5, 2023

The Hidden Truth Studies have shown that the antineoplastic residues can be found be on the external packaging of both oral and IV drugs. Change gloves every 30 minutes during compounding or immediately when damaged or contaminated, unless otherwise recommended by the manufacturer's documentation.

Compounding 52

Compounding Packaging Hospitals Chemotherapy 52

European Pharmaceutical Review

JANUARY 25, 2024

These standardised documents provide meticulously curated and scientifically approved information. Within the EU, patient information leaflets (PILs) are not merely a regulatory requirement but a cornerstone of patient safety. They detail the medication’s intended use, proper administration, potential side effects and precautions.

Packaging 98

Packaging Documentation Communication Pharmaceutical Companies 98

GMPSOP

MAY 17, 2024

Regulatory requirements for GMP 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.

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Documentation Packaging Pharmaceutical Manufacturing Compounding 52

GMPSOP

MARCH 17, 2023

Additional documents included each month. In a packaging line, a printer was used to imprint manufacturing and expiry dates on a batch of empty cartons which will be used to fill tablet strips. Further to corrective action, the defective packaging (carton) lot was destroyed which was initially quarantined.

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Documentation Packaging Process Improvement Pharmaceutical Manufacturing 52

GMPSOP

FEBRUARY 25, 2023

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.

Labelling 52

Labelling Packaging Documentation Pharmaceutical Manufacturing 52

GMPSOP

JUNE 16, 2023

According to USP <1224> , method transfer is defined as the documented process that qualifies a laboratory (RL) to use an analytical method originating from another laboratory (TL), regardless of whether it’s internal or external. Additional documents included each month. Additional documents included each month.

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Documentation Dosage Communication Method Validation 52

National Association of Boards of Pharmacy

NOVEMBER 6, 2024

A Policy & Procedure (P&P) assessment is sent to you to help prepare and organize your documents for submission. Post-Survey Remediation NABP presents to you a post-survey letter where the survey findings are given. Application Submit the online application and payment, and NABP reviews the application.

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Specialty Pharmacies Packaging Documentation 45

European Pharmaceutical Review

JANUARY 13, 2025

Our research has demonstrated that these redeveloped inhalers for asthma and COPD, which use carbon-minimal propellant gases, present an effective solution for minimising their carbon emissions 5 and builds on our foundations of transitioning to more environmentally conscious solutions. 5 However, the benefits are well documented.

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Packaging Community Pharmacies Documentation Pharmaceutical Companies 52

Pharmaceutical Technology

SEPTEMBER 26, 2022

Given the conflict present in the eastern part of Ukraine from 2014, sponsors, investigators and logistics providers were prepared for potential disruption. CROs and sponsors use remote source document verification, as approved by the regulator pre-war. In July, approximately a third of companies had paused a trial in the country.

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Packaging Documentation 52

Quality Matters

JUNE 14, 2023

Beyond addressing proper documentation, storage, and transportation, GDPs incorporate appropriate mitigation strategies to control the foreseeable risks. Through implementation of GDP regulations, supply chain security methodologies, and a focus on patient safety, ANVISA has helped protect and promote public health in Brazil, Fujimoto said.

Dosage 52

Dosage Packaging Documentation Hospitals 52

GMPSOP

JULY 14, 2023

Additional documents included each month. In other areas, such as in secondary packaging or in material storage areas, the product isn’t exposed to the environment, so there is a lower risk of contamination. Additional documents included each month. 240 SOPs, 197 GMP Manuals, 64 Templates, 30 Training modules, 167 Forms.

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Documentation Labelling Pharmaceutical Manufacturing Packaging 52

Pharma in Brief

JANUARY 9, 2022

The Minister of Health has indicated that the reason for the most recent six-month delay is to provide additional time for impacted stakeholders to focus their efforts on responding to the challenges presented by the COVID-19 pandemic. The Amendments and the accompanying Guidelines continue to be the subject of ongoing litigation.

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Documentation Labelling Vaccines Packaging 52

GMPSOP

DECEMBER 6, 2024

Additional documents included each month. Examples include oil leaks from equipment in a packaging line or small solvent spills in the printing and labeling machine. Additional documents included each month. Additional documents included each month. Additional documents included each month.

Health and Personal Care Stores 52

Health and Personal Care Stores Labelling Documentation Packaging 52

Quality Matters

NOVEMBER 11, 2022

Nitrosamines’ emergence in drug products Nitrosamines are organic chemical compounds that may be present in low levels in a wide variety of products such as processed meats, cosmetics and cigarette smoke. FDA and other global regulatory agencies have issued public health alerts and guidance documents for manufacturers.

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Packaging Documentation Compounding Diabetes 52

PharmaShots

JUNE 1, 2023

We presented our first results this year at ESMO and ESMO-IO. These new results reinforce our differentiating data package for PDC*lung01. The target population of PDC*lung is initially limited to HLA-A2+ patients, as the PDC*line HLA-A2 cell line is used to load and present the selected antigens.

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Immunity Immunization Vaccines Health and Personal Care Stores 40

Quality Matters

JUNE 6, 2023

The complexities of the excipient supply chain, however, can present unique risks related to quality, regulatory oversight, and overall supply chain resiliency. Sourced from suppliers around the world, excipients are relied on by developers of finished medications everywhere.

Dosage 52

Dosage Packaging Documentation Drug Development 52

GMPSOP

MARCH 4, 2023

Additional documents included each month. Quality management system is primarily involved in ensuring good manufacturing practice (cGMP), good laboratory practice (GLP), good documentation practice (GDP), good automated manufacturing practice (GAMP) etc. Additional documents included each month. Checkout sample preview s.

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Documentation Communication Method Validation Packaging 52

GMPSOP

JULY 31, 2023

We will present the rationale behind the qualification decision and reference that with the GAMP (Good Automated Manufacturing Practice) categories in support of the decision you will make. These requirements mandate that pharmaceutical companies thoroughly document OQ protocols, testing methods, acceptance criteria, and results.

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Documentation Dosage Labelling Data Entry 52

RX Note

MARCH 28, 2024

On top of the requirement above, under Regulation 11(3) , no person shall sell or supply any psychotropic substance on a prescription which is presented to him more than 90 days after date of the prescription.

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Dosage Hospitals Packaging Documentation 40