As we celebrate Nd’s achievement of obtaining ISO 9001:2015 certification, we are delighted to share our success stories regarding our Quality Management System (QMS) and the Pharmaceutical Quality Systems (PQSs) that Nd has established for our clients. When building a new Quality System or upgrading an existing one, the first question should be asked is:…
Building A Fit for Purpose Quality System Read More »
Often on projects in the pharmaceutical industry, we are asked various questions regarding cross-contamination prevention. It could be a greenfield project for a multi-products and multi-purpose manufacturing facility, an NPI (New Product Introduction) project in an existing facility, or a compliance remediation project. There’s no simple answer to questions like, “Can the two products share
Preventing cross-contamination in the pharmaceutical industry Read More »
Suspension of a site’s GMP certification imposes substantial stress and impact on business, as well as the potential shortage of market supply. This case study outlines how the No deviation team supported a China-based biologics manufacturer to bridge the compliance gaps and achieve the ‘State of Control’ – a condition in which the set of
GMP certification case study: Back in the State of Control Read More »
Raise your hand if you have mixed feelings about inspections, regardless of whether they’re internal audits, the ones from your client/MAH or, perhaps the scariest, from the Health Authorities. Is preparing for an audit the busiest time on site – everyone’s bearing extra workload and stress on top of the routine work? Meanwhile, so very
Are you inspection ready? Read More »
Article 7.4 of EU Directive 2003/94, which lays down the principles and guidelines of GMP, requires that: ‘The personnel shall receive initial and ongoing training, the effectiveness of which shall be verified,…’ When it comes to designing and delivering GMP training, we take into full consideration that – The depth and length of modules are
How to provide effective GMP training in the pharma industry Read More »
I might be saying it too often: the pharmaceutical industry is highly regulated. But what regulates our practices? It could be federal codes, regulations, directives or even guidance. There are national or regional legislations and there are international harmonisations. For anyone working in this arena or for anyone working in the industry, how do we
Regulation Mind Map for the pharmaceutical industry Read More »
1.Tell us more about your role at No deviation. I joined No deviation with a background in process SME, and the company has since helped my development in the domain of Quality and Compliance. I’d very much love to pass on my knowledge, experience and passion to the talent within No deviation and our industry.
Talk to the expert: Shanshan Liu, Director, No deviation Read More »
Just starting out in the pharmaceutical industry or an industry veteran who still has some confusion around these two terms? Let’s look at some fundamentals! There could be a dizzying amount of regulations and terms in the pharma industry. Even for me, who’s been here for more than 15 years, I still find myself learning
Quality or Compliance? Read More »
Following the discussion in Part 1, which covered Pharmaceutical Packaging – Quality by Design, this part will look into Procedures, which is also a Critical Design Element (CDE) besides Equipment and Facility. Without procedures, the ‘State of Control’ is impossible to achieve. For instance, equipment will not be maintained in the ‘qualified status’. As another
Pharmaceutical Packaging: a critical aspect to ensure patient safety – Part 2 Read More »
Background Working in the pharmaceutical industry, ‘recall’ might be one of the words nobody wants to hear. It could indicate a series of consequences, from critical ones of harming patient safety to major ones of tarnishing a company’s reputation. Unfortunately, despite the regulators’ and industry’s best efforts, pharmaceutical packaging remains one of the principal reasons
Pharmaceutical Packaging: a critical aspect to ensure patient safety – Part 1 Read More »
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