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QA/QC Drug Manufacturing Process

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 …

Audit Trails: Your Map to Data Integrity

Technological advancements in pharma labs are making regulatory compliance increasingly complex. And that means audit trails are also increasing in importance. What is an audit trail? Audit trails are a secure, computer-generated, and time-stamped electronic record that allows for the recreation of a course of events. This can involve the creation, modification, or deletion of …

Typically, both drug substance and drug product are tested in at least two different storage conditions: long term ambient storage temperature and accelerated conditions predicting product stability over a long period of time. The purpose of stability testing is to understand how the quality of an Active Pharmaceutical Ingredient (API) varies when different environmental factors …

Meeting standards for Good Manufacturing Practice (GMP) compliance is increasingly difficult for pharma labs. Regulatory bodies around the globe enforce these standards. In the U.S. alone, the FDA’s Office of Manufacturing Quality issued 81 warning letters to manufacturers of finished products in the fiscal year that ended in September 2019. Forming a partnership with third …

The impurity N-nitrosodimethylamine (NDMA) was first detected in Sartans (e.g. Valsartan). The “Sartan” family is typically used for the treatment of blood pressure and if it is used over a long period can eventually expose the patients to carcinogenicity effects even in trace amounts. In 2019, much like Sartans, NDMA was detected in Ranitidine, a …

Pharmaceutical boards, regulatory agencies, and drug manufacturers work to ensure that they maintain the highest standards for public health and safety. To make sure that these expectations are met, regulations are put in place – from the Food and Drug Administration to the Medicines and Healthcare products Regulatory Agency and the World Health Administration – …

Prescription and over-the-counter medicines need to meet the expectations of the public, which requires that they’re safe, effective, and transparent about any possible risks. To do this, there have to be standards and regulations in place that guarantee pharmaceutical quality. That’s where Good Manufacturing Practices (GMPs) and Current Good Manufacturing Practices (cGMPs) come into play. …

Whenever a new instrument is introduced into a pharmaceutical lab, it is normally commissioned through a process of qualification and validation. Depending on a company’s policy, this process is probably based on the most recent USP 1058 or GAMP 5… or a combination of both. Use of a User Requirements Specification (URS) document is recommended …

Analysis of incoming excipients and active pharmaceutical ingredients (APIs) is a crucial aspect of a pharmaceutical QA/QC laboratory. Identification and/or verification of raw materials used in the manufacturing process forms a central pillar of current good manufacturing guidelines (cGMP). Failure to abide by these regulations can lead to issue of an FDA form 483, demonstrating …

The International Council for Harmonisation (ICH) recently issued the Q12 guideline on technical and regulatory considerations for pharmaceutical product lifecycle management. The guideline has now reached Step 4 of the process. The guideline promotes innovation while strengthening quality assurance to improve management of post-approval changes in chemistry, manufacturing, and control (CMC). The Q12 guideline complements …

It’s not always easy to figure out whether your software is 21 CFR Part 11 compliant or compatible. Regulations for 21 CFR Part 11 state that electronic records, electronic signatures, and handwritten signatures converted into digital copies are all trustworthy, reliable, and equal to handwritten signatures on paper. Computerized systems – including hardware and software …

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