Piramal Pharma Solutions Blog

Piramal Pharma Solutions Blog

Piramal Pharma Solutions

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Quality by Design in Pharmaceutical Development

Posted on May 8, 2017 2:32:29 PM by Piramal Pharma Solutions

Quality by Design (QbD) is a systematic approach to product development that begins with predefined objectives and emphasizes product and process understanding and controls based on sound science and quality risk management (ICH Q8). The emphasis of QbD began with the recognition that increased testing does not essentially improve product quality; however, quality must be built into the product. The regulatory agencies encourage risk-based approaches and the adoption of QbD principles in drug product development and manufacturing. At Piramal we are applying a QbD approach in product development, which is characterized by the following principles:

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Safe Handling of Highly Active Compounds

Posted on Nov 30, 2016 10:54:37 AM by Piramal Pharma Solutions

Our facility located in Lexington, Kentucky is a unique parenteral manufacturing site that uses isolator technology to manufacture sterile products with varying degrees of pharmacological activity in the same facility. The risks associated with handling highly pharmacologically active products (some term as potent or cytotoxic) can cause concern in the industry; however experts in toxicology, industrial hygiene, chemistry, safety, and quality assurance agree that a risk-based approach to safety is most appropriate.1, 2 There are no regulations or guidelines that prescribe a mandated approach or require segregation of products based on pharmacological activity. There is, however, a lot of interpretation and misunderstanding across the industry.

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The QP in the EU

Posted on Nov 29, 2016 2:14:31 PM by Piramal Pharma Solutions in product development, in gmp, in manufacturing

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Why It's Never Too Early to Start Considering Clinical Supplies as Part of Your Development Program

Posted on Nov 7, 2016 2:26:44 PM by Piramal Pharma Solutions in clinical supplies, in clinical trials

All too often the planning process for clinical supplies begins after the clinical program is set in stone and the clock is ticking. It is not uncommon to have less than 30 days from first discussions to having a requirement for supplies to be at clinic. For this reason many providers can now offer off the shelf solutions using current equipment and technology. While this may be considered acceptable, the consequences of such decisions are often costly not only financially but also because a complex chain of events has initiated that will ultimately prove challenging to undo.

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Thinking Inside the Box - Isolator Technology for Aseptic Manufacturing of Parenterals

Posted on Oct 3, 2016 2:01:35 PM by Piramal Pharma Solutions in parenteral manufacturing, in parenteral development, in isolator technology, in aseptic manufacturing

The manufacture of parenteral pharmaceuticals is a high stakes endeavor because any product imperfections, whether chemical or biologic in nature, are equally as bioavailable as the active ingredients. Patient safety and product quality are always a concern in pharemaceutical manufacturing, however, the risks are amplified for parenteral products that in many cases are directly injected into the bloodstream. This means the impact of product quality risks are higher than for any other pharmaceutical presentation. The use of isolator technology is a state-of-the-art engineering solution to mitigate manufacturing risks, improve the safety of injectable drug products, and provide a measure of safety to those who are manufacturing the products.

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Integrated Solutions for Extractables and Leachables

Posted on Sep 27, 2016 10:02:46 AM by Piramal Pharma Solutions in sterile manufacturing, in extractables and leachables

Studies of extractable and leachable components (E&L) within packaging systems and pharmaceutical container closures have become mandatory to meet the safety requirements for marketed medicines over the past two decades. The regulatory guidance for E&L provides only general recommendations to ensure safety. The development and analysis of E&L for inhalation, ophthalmic, and injectable drug products is challenging since studying them depends on the type of formulation and packaging material being used.

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Drug Delivery Methods and Therapies for Cancer Treatment

Posted on Sep 8, 2016 10:49:52 AM by Piramal Pharma Solutions in parenteral manufacturing, in parenteral development, in sterile manufacturing

Cancer is a widely known disease involving abnormal and uncontrolled cell proliferation resulting in solid tumor development or blood cancer conditions. Therefore, when it comes to fighting cancer, the aim is to kill the cancerous cells and/or inhibit the uncontrolled proliferation.

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PMP: Exposure to Global Project Management Methodology

Posted on Aug 15, 2016 3:36:43 PM by Piramal Pharma Solutions

At Piramal Pharma Solutions customer satisfaction is of utmost importance and we strive to meet our customers’ needs in every way we can. Our main goal is to deliver quality products within scope while still keeping budgets and timelines under control. One of the ways Piramal Pharma Solutions does this is by training project managers on best practices in the project management industry; an effective way to learn this methodology and keep current on best practices is to obtain a Project Management Professional (PMP) certification.

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Cleaning Verification Method by HPLC – UV: How Fast Can We Go?

Posted on Jul 26, 2016 2:31:58 PM by Piramal Pharma Solutions

Cleaning verification represents the start and finish of each batch in pharmaceutical manufacturing. Two commonly applied analytical approaches to verify pharmacological cleanliness are: total organic carbon (TOC) and high-performance liquid chromatography (HPLC). TOC is a non-specific technique with analysis times ranging from 2 to 10 minutes, depending on the analytical instrument. HPLC has the advantages that methods can be developed for specific analytes and the limit of detection can be one to two orders of magnitude lower than TOC. Due to this, HPLC-UV is a popular cleaning verification (CV) method.

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Liposome Drug Delivery

Posted on Jul 5, 2016 10:58:16 AM by Piramal Pharma Solutions in parenteral manufacturing, in parenteral development, in sterile manufacturing, in product development

The global market for NDDS in cancer therapy was valued at USD 3,655.3 million in 2013 and is expected to reach USD 15,984.2 million in 2020, growing at a CAGR of 23.7% during the forecast period from 2014 to 2020.

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