MANUFACTURER OF HIGH PURITY SPECIALTY CHEMICALS

Transcription

1 The IPEC Excipient Stability Program Guide 2010 MANUFACTURER OF HIGH PURITY SPECIALTY CHEMICALS For the, nutraceutical, pharmaceutical, food & other specialty markets 1

2 Jost Chemical Founded by Jerry Jost in employees Facilities expansions in & ,000 ft 2 plant in St Louis, MO. SALES & MARKETING offices in US and EUROPE WAREHOUSING in the USA (MO, NJ, CA) In EUROPE (Antwerp, BE) 2

3 JOST CHEMICAL A Jost Manufacturing Area 3

4 Dryer Philip H. Merrell, Ph. D Jost Chemical Over 150 Products Manufactured ASCORBATES CARBONATES CITRATES FUMARATES GLUCONATES LACTATES MALATES NITRATES PHOSPHATES SUCCINATES SULFATES OXIDES 4

5 Jost Chemical Manufactures every product in St. Louis facilities (not a distributor) FDA Registered and Inspected (biannually) Full cgmp Compliance for Bulk API s Total QA All All QSP, SOP, documents Jost Chemical Total QC Full testing onsite including ICPMS, AA, Particle size, Microbiology ALL tests are done in our lab Experts that can answer all questions and answer all complaints 5

6 Jost Chemical Highly developed Customer Service Smallness means rapid response Jost is Gold Standard for supplying mineral salts for dietary supplements ALL advantages of larger companies with fewer of the weaknesses Jost Lab 6

7 Jost Microbiology Lab Some Jost Pharmaceutical Products Ammonium Phosphate Mono- and Dibasic Ammonium Sulfate NF/ACS Cupric Sulfate Pentahydrate USP Ferric Ammonium Sulfate Purified Manganese Sulfate Monohydrate USP/EP/ACS Potassium Phosphate Monobasic NF/ACS Potassium Phosphate Dibasic USP?ACS Potassium Sulfate EP/ACS Sodium Carbonate Anh NF/EP/JP/ACS Sodium Carbonate Monohydrate NF/ACS Sodium Phosphate Monobasic Anh and Monohydrate Sodium Phosphate Dibasic Anh and 7-hydrate Sodium Phosphate Tribasic Dodecahydrate Sodium Sulfate Anhydrous USP/ACS 7

8 Stability Guide Philip H. Merrell, Ph. D Jost Chemical ICH Q1 and Q1A Intended for registration of new molecular entities and associated drug products Q1 September 16, 1992 Q1A October 27, 1993 Q1A(R) April, April, 2000 Q1A (R2) August

9 ICH Q1 and Q1A Studies done at room temperature (25 C+/ C+/-5 C) C) and humidity (60%+/-5%) Repeated with new lot every year Q1A intended for finished goods drugs that are stored on shelves in drug stores and then at home Q1A makes sense for those products BUT industry adopted this guide for all pharmaceutical products---it is the only guide for stability Jost Chemical Warehouse 9

10 The IPEC Excipient Stability Program Guide 2010 Stability Issues for Excipients No guide for stability of excipients Have long history of use Considered stable or at least those not stable are known Stored in warehouses with no environmental controls Transported with no concerns for environmental controls 10

11 IPEC Stability Guide History of successful storage and transport Excipients that require controls are known User regularly tests excipients and know that the storage has not effected the product Very few truly new excipients New guide tries to be scientific as much as possible Very Stable IPEC Stability Guide Stable at least 5 years Stability predicted based on known chemistry Changes in process not expected to change stability Stable 2-5 years of data Change in process may or may not affect stability 11

12 IPEC Stability Guide Limited Stability Re-evaluation evaluation interval of less than 24 months Clear stability indicating markers Limited stability data to support re-evaluation evaluation date Change in process or package requires new stability study Stability New Products Very few new excipients Scientist should know stability characteristics of their new products Potential for interaction with Oxygen, Carbon Dioxide, Water, Light Hygroscopic (pick up or lose water) Decomposition products (not at high temps.) Choose packaging and set-up Stability Study based on above 12

13 Distributors If product is repacked or reworked in any way, distributor is responsible for stability studies Reputable distributor may be repacking for a specific user who will be able to run tests (many distributors do not have labs) Can enter into an agreement where the user tests the product during the stability run Bottom Line: Stability The stability information should guarantee that when the user opens the drum during the warranted time, the product still passes all specifications If the product is stored and transported under uncontrolled conditions, controlled stability studies do not really apply 13

14 How to Conduct Stability Studies Utilize historical data including that found in the literature or test product from drums stored in the warehouse and generate a report summarising the data and drawing conclusions about excipient stability Conduct a study using the excipient packed in the commercial packaging placed in one or more warehouses which are used to hold the product, and where the temperature of the warehouse is monitored (but not controlled) Stability Studies Conduct a study using the conditions and recommendations in ICH Q1A(R2). Normally only for excipients that are known to have or suspected of having limited stability Not really reflective of the stability if the product will be stored in an uncontrolled warehouse For limited stability product may have to have warehouse area with controlled environment 14

15 Stability Protocol Objective of the study Scope of study (what products, codes, types of packaging) Selection and justification of representative batches Selection and justification of the container and closure system as the worst case Storage conditions Sampling plan 0, 3, 6, 9 mos,1, 2, 3, 4, 5yr Stability Protocol Stability indicating test methods Out of specification results (if necessary) Acceptance criteria Approval process Interim and Final Report Content 15

16 Stability Final Report Covers what products (codes) In described container closure system(s) Actual Data Recommended re-evaluation evaluation date based on data Requisite approvals and date 16