Pharmaceutical Technology

SEPTEMBER 5, 2022

Wholesalers can be either full-line wholesalers, who purchase the complete product line of a company, or specialised companies, which purchase speciality drugs to sell to clinics and hospitals. Selecting the best pharmaceutical wholesalers. Temperature control facilities and supply solutions. Warehousing and logistics services.

Documentation 52

Documentation Packaging Labelling Pharmaceutical Manufacturing 52

Eye on FDA

AUGUST 2, 2022

There are two means of gaining insight into the agency’s thinking about regulatory issues related to promotional communications by pharmaceutical companies; one is through the issuance of guidance documents, the other is through enforcement. But when it comes to enforcement things have changed greatly over the years.

Communication 88

Communication Pharmaceutical Companies Pharmaceutical Companies Documentation 88

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

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

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

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

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

Viseven

JULY 25, 2024

Promoting content worldwide When a pharmaceutical company publishes content, it often considers the norms and laws of the country in which it operates. But what if this company decides to expand worldwide? Just a small error could lead to many people adhering to compliance documentation and making the same mistake in their work.

Documentation 52

Documentation Communication Pharmaceutical Companies Pharmaceutical Companies 52

Pharmaceutical Technology

SEPTEMBER 15, 2022

The pharmaceutical industry requires specialised and cost-effective commercial packaging solutions to improve efficiency and preserve the integrity of products through the entire supply chain, from primary packaging and labelling to shipping, delivery, storage and distribution to end users.

Packaging 40

Packaging Labelling Pharmaceutical Manufacturing Documentation 40

Eye on FDA

JANUARY 9, 2022

As noted in the past, there are two primary means for understanding the agency’s latest thinking with respect to promotional communications from pharmaceutical companies – the content and pattern of enforcement and the issuance of guidance documents to shed light on the parameters that exist.

Communication 64

Communication Documentation Labelling Pharmaceutical Companies 64

pharmaphorum

AUGUST 31, 2021

ECAs are being used to support the primary approval, label expansion of their assets and even go/no-go decisions for trials. Beyond the FDA, other institutions have documented what industry standards should look like in assessing RWD in a regulatory context. Furthermore, ECAs are well-documented in the post-approval setting.

Insurance Coverage and Processing 89

Insurance Coverage and Processing Drug Development Documentation Labelling 89

GMPSOP

FEBRUARY 15, 2024

Quality assurance inspectors destroy all unused labels and inserts from the Packaging Lines. Additional documents included each month. Subscribe General housekeeping practices Housekeeping practices in a pharmaceutical facility have the same connotation as housekeeping in a home. Additional documents included each month.

Documentation 52

Documentation Labelling Compounding Packaging 52

GMPSOP

JUNE 28, 2024

Additional documents included each month. Adulterated Pharmaceuticals: 396 warnings iii. Packaging/labeling/Misbranding: 41 warnings vi. Similarly, the packaging, labeling, and misbranding-related warning letters were the top reasons in 2019. Additional documents included each month. Checkout sample preview s.

Documentation 59

Documentation Packaging Labelling Pharmaceutical Manufacturing 59

pharmaphorum

OCTOBER 27, 2022

The Guidance applies to all member companies of EFPIA and IFPMA, but also acts as useful guidance for all pharmaceutical companies as to how the authorities will interpret the legislative provisions to social media channels. Therefore, companies are encouraged to establish a methodology for calculating fair market value rates.

Communication 98

Communication Pharmaceutical Manufacturing Packaging Documentation 98

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. All written and updated by GMP experts.

Documentation 52

Documentation Method Validation Packaging Data Entry 52

GMPSOP

DECEMBER 6, 2024

All waste generated during the cleanup should be disposed of properly in labeled bags, and the equipment used must be cleaned and stored appropriately. 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.

Health and Personal Care Stores 52

Health and Personal Care Stores Labelling Documentation Packaging 52

GMPSOP

FEBRUARY 10, 2024

GMP/GLP and PPE training are applied to all employees, contractors and casual staff working in a GMP environment, including manufacturing, packaging, labelling, distribution, QA, QC, development, validation, engineering, IT staff and anyone whose activities could affect product quality. Additional documents are included each month.

Health and Personal Care Stores 52

Health and Personal Care Stores Documentation Packaging Compounding 52

Eye on FDA

JULY 7, 2020

The drug in question is Schedule II drug and bears a Boxed Warning on its label, yet the link contained no risk information about the drug, despite the fact that there was present information about the benefits of the drug, according to OPDP’s letter. This item disappeared from the agenda, however, and no draft guidance was issued.

Communication 52

Communication Documentation Labelling Pharmaceutical Companies 52

GMPSOP

MARCH 8, 2024

– Please make sure that proper documentation is maintained and corrective action is undertaken. The FDA subsequently published several guidance documents regarding this matter. Additional documents included each month. Each tablet has the label claim of 100mg (w/w). Additional documents included each month.

Documentation 52

Documentation Dosage Pharmaceutical Manufacturing Packaging 52

Viseven

NOVEMBER 17, 2022

They provide information about the following: Off-label usage Publications Safety information Independent medical education. Under its internal affairs, the pharmaceutical ones bring together the research and commercial wings of the pharma businesses. The role of medical affairs in pharmaceutical companies.

Communication 52

Communication Pharmaceutical Companies Pharmaceutical Companies Documentation 52

European Pharmaceutical Review

JULY 4, 2024

However, as with drugs, dietary supplements require evidence that they are safe and that claims on product labels are truthful and not misleading. Prior to joining Fieldfisher, Taly spent four years working as in-house counsel for a leading tech company helping launch products across multiple EU markets.

Drug Development 103

Drug Development Documentation Labelling Biosimilars 103

GMPSOP

MARCH 20, 2024

Additional documents included each month. Additional documents included each month. You should identify and document the instrument ID, date and time of calibration, units of measurement, the standards used, the steps taken during calibration, and environmental conditions. Additional documents included each month.

Documentation 52

Documentation Pharmaceutical Manufacturing Labelling Communication 52

GMPSOP

APRIL 3, 2024

A pharmaceutical warehouse is responsible for receiving, storing, and releasing incoming goods (including labeling and packaging) and distributing finished products. Therefore, GMP rules ensure that materials are handled and stored properly and that appropriate documentation is maintained. Checkout sample preview s.

Labelling 52

Labelling Packaging Documentation Inventory Control 52

GMPSOP

MARCH 3, 2024

You should not be unfamiliar with it if you know how pharmaceutical facilities operate. Cross contamination in pharmaceutical industry is a serious issue which can affect the quality and safety of drugs. What are the examples of cross contamination in pharmaceutical industry? Additional documents included each month.

Health and Personal Care Stores 52

Health and Personal Care Stores Labelling Packaging Documentation 52

GMPSOP

DECEMBER 10, 2023

Packaging and labelling mix-ups can potentially result in serious health consequences. Accurate labelling of medicines is critical to patient health. Therefore, manufacturers pay particular attention to getting the right medication and strength into the right container with the correct labels and instructions for use.

Packaging 40

Packaging Health and Personal Care Stores Labelling Documentation 40

GMPSOP

NOVEMBER 15, 2024

Stability and container closure systems Stability testing should be conducted on the proposed dosage form that is to be included in the container closure system (including, as appropriate, any secondary packaging and the container label). Additional documents included each month. Additional documents included each month.

Packaging 59

Packaging Dosage Documentation Labelling 59

GMPSOP

JULY 31, 2023

The FDA sets stringent requirements for operational qualification for critical equipment and systems to ensure the safety and efficacy of pharmaceutical products. These requirements mandate that pharmaceutical companies thoroughly document OQ protocols, testing methods, acceptance criteria, and results.

Documentation 52

Documentation Dosage Labelling Data Entry 52

GMPSOP

APRIL 26, 2025

A customer information bulletin (CIB) is typically a document containing information similar to that within a safety alert but of lower significance. Ensure proper documentation, effectiveness checks, and final reporting to close actions. Additional documents are included each month. Additional documents are included each month.

Documentation 52

Documentation Communication Labelling Customer Service 52

FDA Law Blog: Biosimilars

MAY 26, 2025

The gray box at the top of the document at this link shows the change in position. Were not trying to bury the lead here, but the battle of labeling these surgical and drug treatments is a political one. Specifically, these are procedures and drugs used in providing what HHS had, until recently, referred to as gender-affirming care.

Labelling 59

Labelling HIPAA Documentation Pharmaceutical Companies 59