article thumbnail

Six steps process to implement change control management

GMPSOP

Change control management is a systematic process by which a change to facilities, products, systems, or processes is proposed, assessed by a committee (technical and operational impacts), approved, implement, reviewed for effectiveness, and communicated to a larger audience. All documentation must be kept as supporting evidence.

article thumbnail

Six steps process to implement change control management

GMPSOP

Change control management is a systematic process by which a change to facilities, products, systems, or processes is proposed, assessed by a committee (technical and operational impacts), approved, implement, reviewed effectiveness, and communicated to a larger audience. All documentation must be kept as supporting evidence.

Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

Trending Sources

article thumbnail

Mastering Responses to FDA 510(k) AI Letters: A Strategic Approach

FDA Law Blog: Biosimilars

FDA communicates via a Substantive Interaction to inform the submitter either that FDA will proceed with Interactive Review or that the 510(k) will be placed on hold until FDA receives a complete response to an Additional Information request. By Day 15 FDA conducts Acceptance Review. By Day 60 FDA conducts Substantive Review.

article thumbnail

Supplier qualification standard aims to strengthen supply chains for quality medicines, dietary supplements, and foods

Quality Matters

They comprise interconnected webs of local and global ingredient suppliers, manufacturers, packagers, distributors, providers, and regulators. active ingredients, excipients, other raw materials) Packaging materials (e.g., Global supply chains are complex and vulnerable to disruption.

article thumbnail

New IFPMA and EFPIA guidance on use of social media by the pharmaceutical industry

pharmaphorum

The overarching principle set out in Codes of Practice, and in particular the Principles for the use of digital channels in the EFPIA Code , is that the legislation and Codes of Practice apply equally to communications by companies on social media and digital channels.

article thumbnail

A step-by-step guide to successful installation qualification (IQ)

GMPSOP

Installation qualification will provide you with documented evidence that the equipment or system has been designed, developed, supplied, and installed in accordance with design drawings, the supplier’s recommendations, and in-house user requirements. Additional documents included each month. Checkout sample preview s.

article thumbnail

Warehouse material handling for pharmaceutical industry

GMPSOP

When the raw materials, components, and packaging materials arrive from the supplier, the first thing you should do is verify the goods match with records such as purchase order and delivery docket. It is important to assign in-house lot numbers for every container received next to the supplier’s lots of raw materials or packaging materials.