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.

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Pharmaceutical Technology

SEPTEMBER 5, 2022

Pharmaceutical wholesalers act as intermediaries between pharmaceutical manufacturers and retailers and facilitate the delivery of the right medicines in a timely, efficient, and secure manner. Selecting the best pharmaceutical wholesalers. Temperature control facilities and supply solutions.

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pharmaphorum

SEPTEMBER 30, 2022

Component management is fairly new to the regulatory market, with pharmaceutical firms moving from traditional document management systems to more dynamic component content management systems. Most of the information is submitted in the form of unstructured PDF documents, with data embedded into them. Submission status quo.

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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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GMPSOP

FEBRUARY 28, 2024

This article will explore the key considerations, best practices, and regulatory requirements for effective cleaning and sanitation that pharmaceutical companies must adhere to for optimal cleanliness and safety. Additional documents included each month. Additional documents included each month. Checkout sample preview s.

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GMPSOP

OCTOBER 26, 2022

Table of Contents What is the concept of validation in pharmaceutical industry? ” Validation is a critical concept in the pharmaceutical industry. .” ” Validation is a critical concept in the pharmaceutical industry. Additional documents included each month. All written and updated by GMP experts.

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Pharmaceutical Technology

SEPTEMBER 20, 2022

Contract marketing companies support pharmaceutical companies in creating, improving, and maintaining their brand, as well as reducing risk, and ensuring better product placement in the market. Identifying the top commercial dose (non-sterile) companies in contract marketing.

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Pharmaceutical Technology

SEPTEMBER 14, 2022

Commercial dose companies form a critical component of the pharmaceutical manufacturing industry’s value chain. The dose form manufacturing follows API manufacturing to produce the final dosage form (FDF such as tablets and injectables.

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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).

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GMPSOP

JUNE 28, 2024

Additional documents included each month. Additional documents included each month. Subscribe Different types of deviations in pharmaceuticals There are two types of deviations. If the complaints are persistent, they may reflect a fault in the manufacturing process or formulation. Additional documents included each month.

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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.

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GMPSOP

SEPTEMBER 27, 2023

The practice of calling a piece of equipment clean just because it looks clean is not acceptable in the pharmaceutical manufacturing process. Additional documents included each month. – To conduct the validation studies in accordance with the protocols and to document the results of studies.

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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. The Guidance applies to both product-related and therapeutic-area-related activities.

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GMPSOP

MAY 17, 2024

This article will explore the key considerations, best practices, and regulatory requirements for effective cleaning and sanitation that pharmaceutical companies must adhere to for optimal cleanliness and safety. Additional documents included each month. Additional documents included each month. Checkout sample preview s.

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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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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. .

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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. Additional documents included each month. Additional documents included each month.

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Viseven

SEPTEMBER 14, 2023

Hidden expenses can pile up, spiraling out of control due to many reasons related to supplier performance: the lack of appropriate documentation, storage, wrong dosage forms, and the list goes on. Technologies allow pharmaceutical companies to collect and analyze a massive amount of data to ensure proper drug safety.

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Viseven

JANUARY 13, 2023

So what do exactly HEOR experts do for the pharmaceutical companies and what HEOR-collected data is used for? HEOR collects all reports about health outcomes from patients and physicians and later provides detailed analytics to healthcare providers, clinical outcomes research institutions or pharmaceutical companies.

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GMPSOP

DECEMBER 10, 2023

Therefore, manufacturers pay particular attention to getting the right medication and strength into the right container with the correct labels and instructions for use. Additional documents included each month. Document the results of the inspection in the batch production records. Additional documents included each month.

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GMPSOP

MARCH 20, 2024

Additional documents included each month. Additional documents included each month. SOP for instrument calibration: Instrument calibration is important for pharmaceutical manufacturing standards. Could you document the process in the instrument calibration register and the instrument history file? Subscribe f.

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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. Additional documents included each month.

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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.

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