Stability Studies

At GVK BIO, we execute protocol bound stability studies for both NCE and generic formulations as a part of our global business in accordance with ICH Q1 and custom requirements. We provide a wide range of studies, which supports the critical understanding of API and formulation.

The stability testing support can be provided to IND, NDA, ANDA, and prototype formulation stability. Stability studies are routinely performed at various stages under storage conditions of different temperature and humidity (Real time, Accelerated and Stress studies as per ICH guidelines).

Stability Studies are performed to understand the compounds/formulation in development:

  • Physical & Chemical properties of API and drug product
  • Drug and excipient compatibility
  • Impact of manufacturing process steps
  • Interactions with packaging materials
  • Assignment of shelf life

GVK BIO performs comprehensive stability services virtually for every dosage form. We support the customers at various stages of drug product lifecycle:

  • Early formulation development
  • Formulation development
  • Clinical supplies
  • Drug product registration/marketing authorisation
  • Post approval stability

Stability chambers are available for following conditions with climatic zones I-IV.

ICH Stability Zones

Sl. No.

Zone

Type of Climate

1. Zone I Temperate zone
2. Zone II Mediterranean/subtropical zone
3. Zone III Hot dry zone
4. Zone IVa Hot humid/tropical zone
5. Zone IVb ASEAN testing conditions hot/higher humidity

For OSD and Injectables (not packed in semipermeable containers), we cover stability study for all Zones and product storages, which are:

1. 25 ±2°C / 60 ±5%RH
2. 30 ±2°C / 65 ±5%RH Covers Zone I, II and III
3. 40 ±2°C / 75 ±5%RH
4. 30 ±2°C / 70 ±5%RH Covers Zone IVA(LT)
5. 30 ±2°C / 75 ±5%RH Covers Zone IV B, Brazil, ASEAN (LT)
6. 5 ±3°C (for products to be kept in refrigerator)
7. -20±5°C (for products to be kept in freezer)

In case of products packed in semipermeable containers, following stability conditions are maintained in addition to the above:

  • 25 ±2°C / 40 ±5%RH (LT)
  • 40 ±2°C / NMT 25%RH (ACC)
  • 30 ±2°C / 35 ±5%RH (Intermediate)

We can programme the stability chambers to customised requirements for the following:

  • Temperature and humidity
  • Cold
  • Photo-stability

The various offerings as per ICH guidelines on stability studies are listed below:

  • Exhibit/submission batches
  • Validation batches
  • Commercial batches
  • Support for SUPAC filing

We also offer contingency stability programmes as risk management approach to the clients.

Scientific Studies Involving API or Product Stability

These studies are meant for gaining in–depth understanding of scientific concepts in relation to API and/or drug product stability. These are aimed at supporting customers in:

  • NCE Research
  • Early formulation development
  • Clinical supplies
  • Generic product development

Salient Features

1. Process Driven Stability Programmes

  • Stability studies are conducted in strict adherence to GVK BIO’s internal standard operating procedure meeting global quality guidelines (ICH Q1, CDER and WHO).
  • Stability studies are governed by well designed, client approved stability protocols, which are prepared focusing onto geographic zone specific recommendations of ICH and factors in the dosage form specific aspects.
  • Concurrent documentation of loading and withdrawal of stability samples in to/from stability chambers.
  • Traceability of each and every stability sample ensured by documented positions.
  • Stability chambers are maintained and monitored/alarmed through computerised systems.
  • All the stability chambers have 24×7 back up power supply.
  • Efficient and scientifically driven OOS and OOT investigations.
    • Duration of study
    • Globally acceptable stability program

2. Consultative Approach

GVK BIO actively involves in design of stability protocols and shares its expertise in deciding:

  • Bracketing & Matrixing Strategy
    We offer our expertise in Q1D guidelines of ICH to design and implement bracketing and matrixing strategies for stability programmes to the clients. We study the various factors that include strength, similarity of composition of the products, container closure sizes, manufacturing process employed and applicability, as well as potential risks, before suggesting possible means to reduce number of test samples by a suitable bracketing or matrixing approach.
  • Interpretation of Results
    At GVK BIO, interpretation of stability results is in-depth. We share a critical view on stability results in relation to the product composition, manufacturing process, polymorphism, packaging configuration, Q3 guidelines of ICH on residual solvents and impurities with emphasis on maximum daily dose permitted, and significance of the actual results in view of these guidelines.

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