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QA/QC Drug Manufacturing Process

Data Integrity Compliance in the Digital Age

In today’s highly digitized world, data integrity and computer system validation (CSV) compliance is of paramount importance within the pharmaceutical manufacturing industry. It is necessary to ensure the safety, efficacy, and quality of drugs, and to protect public health. Regulators conduct regular inspections of drug manufacturing facilities to ensure manufacturers are GMP compliant. In the …

Can We Simplify the Evaluation of Pharmaceutical Excipients?

Whether consumers are supplementing their diet with vitamins, taking a daily aspirin, or using an inhaler to relive asthma, they will likely presume the medicines they are prescribed are safe, effective, and of the highest quality. This assumption is, in most cases, correct – the pharmaceutical industry is one of the most highly regulated in …

Drug development technology is evolving rapidly, creating new opportunities for the pharmaceutical industry to produce high-quality targeted large molecule drugs such as biologics and biosimilars. The combination of strict quality guidelines and a complex final product can lead to too much rejected product and slow the pace of drug development. Biologics tend to be large, …

3 Steps to Ensure Data Integrity for Drug Development

Of the 95 warning letters issued by the FDA in 2018 – 54 of them involved data integrity. As with any industry, success depends on following quality standards throughout all aspects of work. For the pharma cycle, it’s extremely vital because drugs that make it to market are expected to be trustworthy. This requires an …

Expertise, Expectations & Excipients in Medicine

Consumers expect that the medicines they need are guaranteed to be effective and safe. This means that throughout the entire manufacturing process, as well as during research and development, all standards of quality are being met or exceeded. While most people are probably unaware of all the ingredients that make up their medicine, pharmaceutical manufacturers …

Risks and Rules of Impurities in Drug Substance and Drug Product

Impurities in drug substances and drug products provide no therapeutic benefit. Heavy metals – arsenic, cadmium, mercury, and lead, for example – are not generally useful in pharmaceutical production… but are still present as impurities. Controlling these substances is not only imperative to the health of patients, but also to the integrity of drug manufacturers. …

Finding Harmony With ICH, Regulatory Authorities and Pharmacopoeias

While harmonization efforts and the leadership of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) and World Health Organization (WHO) have proven helpful in minimizing the prior variance and complexity in the drug development pathway for GMP-regulated labs, their interactions with individual pharmacopoeial monographs, as well as regulatory agencies, …

Removing the Headache from Dissolution Testing

Quality and Compliance – Where You Need Them Most Pharmaceutical labs consider dissolution testing to be one of the critical steps in the drug development process. And it makes its impact at almost every step of the journey, from early product development to late-stage quality control. Dissolution testing helps labs control key variables in the …

Watch Your Batch: Tips for a Smooth Drug Product Release

When it comes to your batch release – whether it’s a drug’s introduction to the market or the return of an existing product – a seamless rollout can save your reputation and minimize overhead costs. Ensuring that you follow standard procedures and protocols is essential in all stages of the process to guarantee success. We’ve …

Investigate OOS Results When They Occur

Manufacturers want to avoid Out of Specification (OOS) results at all costs. This includes all results that don’t fall within the specifications that are established in drug applications, drug master files, or by the acceptance criteria set by the manufacturer. The discovery of an OOS can severely impact the manufacturing process. When an OOS is …

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