Stability Study Services – South Africa

Stability Protocol Preparation (SAHPRA Aligned)

• Long-term, accelerated & intermediate stability study design

• ICH climatic zone–appropriate storage conditions
  (Zone II / Zone IVb as applicable to product & distribution)

• Batch selection, pull points & acceptance criteria

• Finished dosage forms, APIs, cosmetics & nutraceuticals

• Compliance with ICH Q1A–Q1F, WHO TRS & SAHPRA guidance

Stability Report Preparation

• SAHPRA-ready stability study reports

• Scientific evaluation and interpretation of stability data

• Shelf-life / expiry dating & retest period justification

• OOS / OOT assessment and conclusions

• Suitable for new registrations, renewals & post-approval variations

Graphical Trend Analysis

• Assay, impurities, dissolution & critical quality attribute trending

• Statistical analysis with early OOT detection

• Batch-to-batch & strength-wise comparison

• Authority-friendly graphical presentations

SAHPRA Regulatory Query Handling

• Response to SAHPRA stability-related queries and deficiencies

• Shelf-life extension & scientific justification support

• Assistance during SAHPRA review cycles and GMP inspections

Products Supported

• Finished dosage forms (oral solids, liquids, injectables, topicals)

• APIs & intermediates

• Cosmetics & personal care products

• Nutraceuticals & complementary medicines

Why StabilityPro for South Africa?

• Proven experience with SAHPRA submissions

• ICH-, WHO- & Africa-aligned stability documentation

• Authority-acceptable, inspection-ready deliverables

• Reduced regulatory queries & faster approvals

• End-to-end stability documentation lifecycle support