METHOD DEVELOPMENT AND VALIDATION
Method validation is essential for adherence to Current Good Manufacturing Practice (cGMP) and Good Laboratory Practice (GLP) regulations.
PADM scientists have extensive experience in analytical methods and processes and will help you with all aspects of your method validation process, whether you need to validate the existing developed methods or to validate PADM developed methods. PADM has scientists holding M.Pharm / Ph.D. with vast experience in analytical method validation. The strength of PADM is meeting the stringent timeline through collaborative effort with customers.
PADM offers its expertise to support you through the technical and regulatory issues associated with the analytical method validation. Outsourcing your analytical method validation activities will give you the freedom and time to focus your technical staff on its core competencies.
FORCED DEGRADATION STUDIES
Forced Degradation Study is an integral part of validation of most of HPLC methods. It is a tool to check and evaluate methods which have been developed to be stability-indicating. The principle of FDS lies in stressing a drug (and the corresponding placebo) under physical and chemical conditions, which may force the sample to degrade rapidly thereby producing yet unknown impurities. The idea is to simulate the profile of impurities which may develop during a long-term storage of the product.
Following are the stress conditions, we apply
* Elevated temperature
* Light exposure (UV/VIS) (As per ICH guidelines)
* Acidic, basic and oxidative conditions
* Increased humidity
PADM incorporates these studies during development of a new stability indicating HPLC methods. Also, we incorporate this study during method validation exercise, to show that the method is specific and stability indicating.
IDENTIFICATION & CHARACTERIZATION OF IMPURITIES
We bring our expertise to identify the unknown impurities which are more than reporting threshold limit as per ICH guideline for drug substance and drug product. The identification and characterization of impurities shall be performed with modern hyphenated techniques like:
Customers shall be assisted with comprehensive reports and raw data (including chromatograms, spectras, and thermograms) for the above studies. We will assist you in answering any queries from the regulatory bodies after submission of the data.
As a company, PADM encourage open communication with all our stake-holders and the employees. We are happy about what we do and our goal of high quality product and service is achieved with intense focus.
STABILITY STUDY ANALYSIS AT cGMP ENVIRONMENT
PADM maintains a separate, limited access, stability storage room housing stability chambers set to the ICH stability conditions. The chambers are individually monitored and the conditions documented to ensure that they maintain their set temperature and humidity. All chambers are on a generator back-up system to maintain their environmental conditions in the event of power outage. A careful inventory is maintained for each chamber.
PADM shall execute protocol bound stability studies in accordance with ICH Q1. The stability testing support can be provided to IND, NDA, ANDA, and prototype formulation stability.
Fully validated chambers according to FDA and ICH guidelines.
On-site stability storage as a stand-alone service or combined with analytical support.
Electronic environmental controls which meet standard specifications.
Protocol Design, execution of protocol, data analysis, and final report for regulatory submission.
Forced degradation and photo-stability studies.
Stability studies are routinely performed at various time
points under storage conditions of different temperature and humidity (Real time, Accelerated and Stress studies as per ICH guidelines).
Stability chambers are available at the following conditions:
Refrigerated 2oC to 8oC
25o C with 60% Relative Humidity (RH)
30o C with 75% RH
40o C with 75% RH
(Please inquire about customized temperature and humidity storage conditions.)
PADM can work with you to develop stability protocols to meet your regulatory needs. We can create and execute those protocols and remove the burden of administering a stability study to meet your requirements.
PADM scientists shall pull the samples at regular intervals dictated by the stability protocol over the life of the study. PADM can send the samples back to you for testing, or complete the testing here at our state-of-the-art facility and provide you with stability results in a timely manner. We can also maintain a stability summary of your study and deliver a comprehensive stability report at the end of the stability study.
TEMPERATURE EXCURSION STUDY
This study is to provide evidence on how the quality of drug substance and drug product varies with time under the influence of a variety of environmental factors, such as temperature, humidity and light and to establish a shelf life for the drug substance and drug product and recommend storage condition for Drug substance and Drug Products.