Certificate of Analysis Quality Control Asche Basis Creme 50ml Tubes Regensburg, 06.05.2014 Com. No. HPA: 40019589 Testing Order: 00082446 Com. No. Customer: Batch No.: Lot No. HPA: Specification(s): F00168 41265B 1402049101 Chiesi GmbH PV0454 Ident.-No.: Manufacturing Date: Expiry Date: Your Order No.: 14748331 11.02.2014 28.02.2017 130002043-1 Testing Standard: Test Specification Result Viscosity Rotating viscometer (D = 25/s) 5.000 mPas - 20.000 mPas 8.065 mPas Packaging complies to specifications complies Batch No. Bulk note complies 41265 Commodity No. Bulk note complies 40011365 In Process Controls must comply complies TAMC - every 10th batch </= 10² cfu/g not checked TYMC - every 10th batch </= 10 cfu/g not checked Pseudomonas aeruginosa - every 10th batch must be absent in 1 g not checked Staphylococcus aureus - every 10th batch must be absent in 1 g not checked QC-Decision: Date: Released 06.05.2014 Responsible: Dr. Michaela Ruppert Head of Quality Control Haupt Pharma Amareg GmbH Donaustaufer Str. 378 93055 Regensburg This Certificate of Analysis was processed electronically and does not need to be signed. It is based on a test certificate which bears the original signature. Date 06.05.2014 Printed: 06.05.2014 13:52:51 Page 1 of 1 Confirmation of Compliance Product Name: Asche Basis Creme 50ml Tubes Active Ingredient(s): Strength / Potency: N/A N/A Country: GERMANY Dosage Form: Package Size: Package Type: Cream 50 ml / package Tubes Com. No. HPA: Com. No. Customer: 40019589 F00168 Results of analysis see Certificate of Analysis: Batch No. Finished Product: Batch No. Bulk: Manufacturing Date: Expiry Date: Marketing Authorization No. / Clinical Trial Authorization No.: 41265B 41265 11.02.2014 28.02.2017 Ident.-No. Finished Product: Ident.-No. Bulk: 14748331 14731093 N/A No. of Manufacturing Licence: human: DE_BY_04_MIA_2013_0165 / 53.2-ZAB-2677.1 H211H veterinary: DE_BY_04_MIA_2013_0009 / 53.2-ZAB-2677.1 H211T No. of GMP Certificate: human: DE_BY_04_GMP_2013_0011 veterinary: DE_BY_04_GMP_2013_0012 Manufacturer: Haupt Pharma Amareg GmbH Donaustaufer Straße 378 93055 REGENSBURG I hereby certify that the above information is authentic and accurate. This batch of product has been manufactured, primary packaged, secondary packaged and analysed at the above mentioned site in full compliance with the GMP requirements of the local Regulatory Authority, the agreed product specification provided by the customer and the customer accepted manufacturing, primary packaging, secondary packaging and analytical procedures.The batch records were reviewed and found to be in compliance with GMP. This certificate does not include certification according to EU GMP Guide Annex 16 / Annex 13. Comments: Responsible: Dr. Daniela Tausendpfund Qualified Person Haupt Pharma Amareg GmbH Donaustaufer Str. 378 93055 Regensburg Date 06.05.2014 This Confirmation of Compliance was processed electronically and does not need to be signed. It is based on a test certificate which bears the original signature. Printed: 06.05.2014 13:53:07 Page 1 of 1 Certificate of Analysis Quality Control Asche Basis Creme Regensburg, 06.05.2014 40011365 Com. No. HPA: Com. No. Customer: Batch No.: Lot No. HPA: Specification(s): 41265 1401955001 Chiesi GmbH PV0454 Testing Standard: Testing Order: 00080728 Ident.-No.: Manufacturing Date: 14731093 11.02.2014 Test Specification Result Description - appearance homogeneous creme complies Description - color white complies Description - odor pleasant complies Identity Benzyl alcohol HPLC Retention time complies - note complies 1.9 min pH 5,5 - 6,5 5,8 Microscopic examination uniform emulsion complies Viscosity Rotating viscometer (D = 25/s) 5.000 mPas - 20.000 mPas 10.732 mPas Benzyl alcohol HPLC 0,90 % - 1,05 % 0,99 % Loss on drying grav. 60,7 % - 74,2 % 67,7 % QC-Decision: Date: Released 27.02.2014 Responsible: Dr. Michaela Ruppert Head of Quality Control Haupt Pharma Amareg GmbH Donaustaufer Str. 378 93055 Regensburg This Certificate of Analysis was processed electronically and does not need to be signed. It is based on a test certificate which bears the original signature. Date 06.05.2014 Printed: 06.05.2014 13:53:41 Page 1 of 1