samedan logo
 
 
spacer
home > white papers
WHITE PAPERS
Category:

Extractables and Leachables Testing: A Risk Based Approach

RSSL

Pharmaceutical products are in contact with many external components during both manufacture and usage and small amounts of chemicals may leach from these components with a potential health risk to the patient. Extractables and leachables (E&L) studies therefore play an important role in verifying the safety of a drug product over its lifetime. Regulatory organisations such as the US Food and Drug Administration (FDA) and the European Medicines Agency (EMEA) are taking an increased interest in the interactions of various drug delivery devices, pharmaceutical product containers and medical devices with drug product and/or patient and this field is therefore growing in importance. Regulatory guidelines indicate that an extractables profile should be determined for all materials that contact the drug product. Once established, this profile can be used to determine whether any of these extractables are present as leachables within the product. If a leachable is detected, amounts can be determined using validated analytical methods, after which a biological risk can be established based on the exposure. This white paper will provide an overview of the processes used to determine extractables and leachables from plastics.

View White Paper >>

Cleaning Validation: What do you need to consider to ensure a successful outcome?

RSSL

Cross contamination must be avoided in the Pharmaceutical industry at all costs and successful cleaning validation ensures that patients are not put at risk due to cross contamination. The process can be divided into a number of sections each of which must be fully understood and areas of concern addressed to ensure a successful outcome across the entire process. This spans both the manufacturing and subsequent analytical and microbological support. The data used to confirm a positive/successful cleaning validation is underpinned by the results of validated analytical methods. It is essential that these results are truly representative as patient safety is based upon the absence of equipment residues. So what are those areas of concern, what affects your ability to get a successful outcome and what do you need to consider when carrying out a Cleaning Validation exercise?

View White Paper >>

Challenges of Analytical Method Transfer in the Pharmaceutical Industry

RSSL

The development and validation of suitable analytical methods is a critical part of the overall drug-development life-cycle. For the majority of products, particularly those that are clinically successful, the transfer of the analytical method between laboratories will be required. This process is designed to verify that a given laboratory is capable of performing a test method for its intended purpose. This can be performed either internally (at the same company), or, with the on-going increasing trend in outsourcing, to an external Contract Research or Development organisation (CRO or CDO).

View White Paper >>

Finding the Right End-to-End Safety Solution for Your Needs

Bioclinica

With upcoming changes, including the implementation of the International Conference on Harmonisation (ICH) E2B(R3) Electronic Transmission of Individual Case Safety Report and Identification of Medicinal Products (IDMP) standards, the current state of safety reporting can be confusing. Your existing safety system may not be flexible enough to accommodate these changing regulations, which are still moving targets regarding the details needed for a comprehensive solution with the right level of processes, company-to-company integrations and finalized regional rules.

View White Paper >>

Accelerate Your Database Lock Using Clean Patient Optics

Bioclinica

Because a key step towards database lock is obtaining clean data for all patients, the ability to verify that data are clean early accelerates the ability to lock the clinical database. This ultimately shortens the overall study timeline while ensuring the quality of your data. However, this can be challenging when manually reviewing study data, particularly with larger studies.

View White Paper >>

What is process characterization?

EXPUTEC

Process characterization is an essential step in the commercialization of a new (biological) drug. For drug product commercialization, manufacturers must validate the drug’s manufacturing process. This ensures that the manufacturing process delivers consistently a quality product and that the patient is not at risk.

View White Paper >>

What is process characterization?

What You Need To Know About Thermal Shipping Technologies

Temptime Corporation

This paper presents highlights from a thermal performance study conducted by Modality Solutions LLC. The study examined the performance of five shipping technologies commonly used by specialty pharmacies to transport high-value refrigerated specialty medicines against an industry accepted temperature profile standard.

View White Paper >>

What You Need To Know About Thermal Shipping Technologies

How to Reduce Costs of Specialty Pharmaceutical Shipments and Increase Patient Satisfaction

Temptime Corporation

The specialty pharmacy industry could reduce costs by $27.5 million annually (product and call center staff costs only) if visual temperature indicators were used as decision-making tools to determine if medicine should be used or returned when patients suspect heat damage. In addition, 97% of patients surveyed, who received medicine from specialty pharmacies with a visual temperature indicator included in the package, agree that they would want an indicator in all shipments and 95% agree the indicator increased their confidence in the medicines received.

View White Paper >>

How to Reduce Costs of Specialty Pharmaceutical Shipments and Increase Patient Satisfaction

Using Device Strategy to Drive R&D Productivity

Phillips-Medisize



View White Paper >>

Using Device Strategy to Drive R&D Productivity

Managing GxP Environmental Systems to Ensure Data Integrity

Vaisala Ltd



View White Paper >>

Managing GxP Environmental Systems to Ensure Data Integrity
spacer

Member login

E-mail address:

Password:
Remember me


News and Press Releases

Datwyler celebrates official opening of its new production plant with First Line standard in Middletown, Del

• The new facility in Middletown, Del., is Datwyler’s third facility with First Line standard which will be catering to the markets in North and South America • Approximately 120 jobs will be created, with the majority staffed from the local community • With the Middletown facility, Datwyler will be able to increase its global First Line production by 50 percent by 2020 • First Line is specially designed to manufacture biotech and pharmaceutical elastomer components in a fully integrated good manufacturing practice (GMP) environment
More info >>


White Papers

Achieve full compliance with tamper-verification pharma solutions

UPM Raflatac

UPM Raflatac has developed a range of pharmaceutical labelling products to support compliance with the Falsified Medicines Directive on packaging for prescription drugs and high-risk, over-the-counter medicines. Few solutions offer the same ease of adoption for meeting the February 2019 deadline.
More info >>


Industry Events

Respiratory Drug Delivery (RDD®) Europe 2019

7-10 May 2019, Estoril Congress Center, Lisbon

Respiratory Drug Delivery (RDD®) Europe 2019 connects emerging and high-level scientists, academics, industrial and regulatory specialists, and clinicians. It is a must-attend conference for companies involved in research, development, testing or marketing of medicines, devices and services associated with pulmonary or nasal pharmaceutical products. This year, RDD Europe 2019 will be held in Estoril (Lisbon), Portugal, May 7-10, 2019, and, as in previous years is jointly organized by RDD Online and Aptar Pharma.
More info >>

©2000-2011 Samedan Ltd.
Add to favourites

Print this page

Send to a friend
Privacy statement