EN 17141 Cleanrooms and controlled environments – Biocontamination control is a relatively new European standard, introduced in 2020, that establishes and demonstrates best practices to
In 2017, GMP released a draft update to Annex 1, which received a lot of feedback. Now, GMP has released a finalized version of the
The European Union (EU) Good Manufacturing Practice (GMP) for Medicinal Products for Human and Veterinary Use – Annex 1, commonly referred to as GMP Annex
If you use compressed gasses in your cleanroom, ISO 8573 is an important set of guidelines and regulations for your cleanroom, specifically ISO 8573-1:2010. This
Good Automated Manufacturing Practices (GAMP). GAMP is both a technical subcommittee of the International Society for Pharmaceutical Engineering (ISPE) and a set of guidelines for
If you know us, then you know that clean air and water is our passion in life. But what happens when you cannot prove to
ISO 14644 is a standard for cleanrooms that was developed by the International Standards for Organization (ISO). The ISO has been in existence since 1947,
What is the biggest villain in the contamination control and cleanroom world? Particles. Contamination. This contamination can cause yield and financial loss, delays, frustration, and
The following questions will help you ask the right questions when implementing a system thatadheres to 21CFR Part 11. It is important to satisfy the
21 CFR Part 11 outlines the federal requirements that help to ensure that electronic records are trustworthy, reliable, and generally equivalent to paper records and
Water is one of the major utilities used by the pharmaceutical industry. Different grades of water quality are required depending on the different pharmaceutical uses.
We are all too well aware of the adverse effects of particulate matter contamination within parenteral injectable pharmaceutical products and the consequences for patient safety.
Good Manufacturing Practices (GMPs – sometimes referred to as Current Good Manufacturing Practices or CGMPs) are federal regulations set by the FDA to cover how pharmaceuticals
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