European Pharmaceutical Review

AUGUST 25, 2023

The European Commission (EC)’s revised Annex 1 – Manufacture of Sterile Medicinal Products is now effective in the EU. As of 25 August 2023, pharmaceutical manufacturers are required to implement the GMP regulation into cleaning and bio-decontamination procedures for these products.

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European Pharmaceutical Review

JULY 5, 2023

Revised for 2023, the Parenteral Drug Association (PDA) has published an update to its Technical Report No. 43: Identification and Classification of Nonconformities in Moulded and Tubular Glass Containers for Pharmaceutical Manufacturing.

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Pharmaceutical Manufacturing Packaging Documentation Pharmaceutical Companies 96

Pharma Pathway

FEBRUARY 14, 2023

Granules India Limited- Walk-In Interviews for Freshers On 16th Feb’ 2023 Job Description Company Profile: Granules India Limited is an Indian pharmaceutical manufacturing company based in Hyderabad, Indian. Granules India Limited- Walk-In Interviews for Freshers On 16th Feb’ 2023

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Pharmaceutical Manufacturing Documentation 52

European Pharmaceutical Review

JULY 18, 2023

In 2023, the deviation management sector is expected to account for the largest share of the pharmaceutical quality management market. Most of the quality management systems providers are focusing on capturing these large pharmaceutical markets. Also noted in the report was the shift towards cloud-based systems.

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European Pharmaceutical Review

MARCH 13, 2024

FDA inspections Identification of data integrity deviations Of the 70 Warning Letters issued by the US Food and Drug Administration (FDA) so far in 2024, three have identified data integrity issues at pharmaceutical manufacturing sites outside the US. In a letter issued to China-based Sichuan Deebio Pharmaceutical Co.

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Documentation Pharmaceutical Manufacturing 98

Pharma Pathway

FEBRUARY 16, 2023

Granules India Limited- Walk-In Drive for Capsule Filling / Warehouse/ QC On 17th Feb’ 2023 Job Description Company Profile: Granules India Limited is an Indian pharmaceutical manufacturing company based in Hyderabad, Indian.

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Pharmaceutical Manufacturing Documentation 52

Pharma Pathway

FEBRUARY 4, 2023

Granules India Limited- Walk-In Drive for Compression/ Granulation/ Packing/ Engineering/ IPQA / QC/ Warehouse On 5th Feb’ 2023 Job Description Company Profile: Granules India Limited is an Indian pharmaceutical manufacturing company based in Hyderabad, Indian.

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Pharmaceutical Manufacturing Documentation 52

Express Pharma

MARCH 16, 2025

What are the top 3 trends that defined pharma manufacturing in India and globally in 2024? In 2024, the pharmaceutical manufacturing landscape underwent transformative changes, driven by technological innovations, regulatory adaptations, and evolving global demands. per cent of global patents to almost 2 per cent.

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Biosimilars Insurance Coverage and Processing Pharmaceutical Companies Pharmaceutical Companies 98

Pharma Pathway

MARCH 14, 2023

Granules India Limited- Walk-In Interviews for Freshers in Warehouse/ Production On 17th Mar’ 2023 Job Description Company Profile: Granules India Limited is an Indian pharmaceutical manufacturing company based in Hyderabad, Indian.

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Pharmaceutical Manufacturing Documentation 40

Quality Matters

NOVEMBER 5, 2024

Insights from USP’s Medicine Supply Map demonstrate that geographic concentration of pharmaceutical manufacturing anywhere in the world – including within the United States – increases the risk for drug shortages. Promoting geographic diversity of the manufacturing base of U.S.

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Pharmaceutical Manufacturing Packaging Documentation 78

Express Pharma

MARCH 12, 2024

The approval of the revised scheme follows a thorough review by the Scheme Steering Committee, aligning with the updated Schedule-M of the Drugs and Cosmetics Rule, 1945, issued by the Department of Health & Family Welfare on December 28, 2023. Documentation is an altogether different skill without which compliance is not possible.

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pharmaphorum

DECEMBER 28, 2022

An example of this would be ensuring any aseptic facilities meet the new requirements in EudraLex volume 4, annexe 1, which will be implemented in August 2023. Due diligence teams will review your pharmaceutical quality system – to verify if it is operational and effective.

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PharmaState Academy

FEBRUARY 10, 2025

Revised Schedule M: A Complete Guide to Pharma Compliance Introduction Revised Schedule M is a critical update to Indias pharmaceutical manufacturing regulations. It aligns Good Manufacturing Practices (GMP) with international standards, ensuring quality, safety, and efficacy in drug production. What is Revised Schedule M?

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Documentation Pharmaceutical Manufacturing 52

Drug Channels

OCTOBER 10, 2023

I am pleased to announce our new 2023–24 Economic Report on Pharmaceutical Wholesalers and Specialty Distributors , available for purchase and immediate download. pharmaceutical distribution industry. pharmaceutical distribution industry. and Section 6.4.3. A new Section 6.2.2.

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Specialty Pharmacies Biosimilars Pharmaceutical Manufacturing Documentation 40

European Pharmaceutical Review

OCTOBER 3, 2024

While it officially applies to the manufacture of sterile medicinal products in the European Union, the revised EU Good Manufacturing Practice (GMP) Annex 1 effectively reset the benchmark for quality standards across the globe on 25 August 2023.

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Packaging Pharmaceutical Companies Pharmaceutical Companies Pharmaceutical Manufacturing 52

Quality Matters

SEPTEMBER 15, 2023

FDA Guidance on Testing High-Risk Drug Components for Diethylene Glycol and Ethylene Glycol (Disclaimer: The article below includes a discussion of key points of the guidance document. It is not the guidance document, nor it is an alternative to the guidance document. The guidance document is available here: [link].)

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Documentation Compounding Pharmaceutical Manufacturing 52

GMPSOP

MAY 26, 2023

Six steps process to implement change control management Pharmaceuticals quality assurance & validation procedures GMPSOP Six steps process to implement change control management Last modified: June 3, 2023 Table of Contents “It is not the strongest of the species that survive, nor the most intelligent, but the one most responsive to change”.

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GMPSOP

MAY 26, 2023

Six steps process to implement change control management Pharmaceuticals quality assurance & validation procedures GMPSOP Six steps process to implement change control management Last modified: May 28, 2023 Table of Contents “It is not the strongest of the species that survive, nor the most intelligent, but the one most responsive to change”.

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Documentation Packaging Communication Customer Service 52

GMPSOP

JUNE 28, 2024

Additional documents included each month. In the five years between 2019 and 2023, the FDA issued the following warning letters, closely related to ineffective deviation investigation. Adulterated Pharmaceuticals: 396 warnings iii. Additional documents included each month. Additional documents included each month.

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Documentation Packaging Labelling Pharmaceutical Manufacturing 59

GMPSOP

SEPTEMBER 27, 2023

Cleaning validation protocol for pharmaceutical industry Pharmaceuticals quality assurance & validation procedures GMPSOP Cleaning validation protocol for pharmaceutical industry Last Updated on September 28, 2023 by Kazi Prev PREVIOUS POST Table of Contents What is cleaning validation in pharmaceutical industry?

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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. All written and updated by GMP experts.

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GMPSOP

JULY 14, 2023

In this article, we will discuss important aspects of equipment cleaning that are required during pharmaceutical manufacturing. Additional documents included each month. 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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Quality Matters

AUGUST 3, 2023

While focuses on evaluating and establishing supplier reliability for pharmaceutical manufacturing companies and compounding pharmacies, its high-level elements of supplier qualification can also be applied to suppliers of foods and dietary supplement ingredients. josh.levin@usp.org Thu, 08/03/2023 - 15:43 Supply Chain

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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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