Questionnaire Online

Dear Customer,
To help us fill your order with the utmost degree of accuracy, efficiency, and according to your needs, we would appreciate it if you would complete this questionnaire as precisely as possible. Thank you very much.

Company
Contact Person
Street
Zip (Postal) Code, City
Country
Phone
Fax
E-mail
Product Name/Code
Batch size
Annual need
Date of delivery
Order is a
commercial batch product development	stability batch clinical sample
1. Galenic form lyophilised parenteral aseptically filled, liquid parenteral sterilized, liquid parenteral other lyophilised product other liquid product other:
2. Type of active ingredient cytostatic antibiotic (except -Lactam) hormone other:
3. Processing Instructions
are available	yes no
are provided	now later
if now, please attach as a file (txt, pdf, doc)
4. Active Ingredient Name    and Specification
quantity / vial
active ingredient provided by the customer	yes no
safety data sheet available	yes no
release of the active ingredient by	Affinity GmbH customer
special properties (i.e. toxicity, instability, etc.)
5. Inactive Ingredients
inactive ingredients provided by the customer, please list
inactive ingredients to be provided by Affinity GmbH, please list
6. Sterile Filtration	yes no
material of filter
	not known
type or brand of filter
	not known
prefiltration	yes no
double filtration	yes no
7. Preparation and Filling
filling quantity / vial
	not known
lyophilisation programme available	yes no
duration of lyophilisation	hrs.
preparation under nitrogen	yes no
filling under nitrogen	yes no
other specific requirements	yes no
if yes, which?
8. Primary Packaging 8.1 Vials
moulded glass tube glass	transparent brown
size	ml or DIN name
specific requirements
vials are provided by the customer	yes no
8.2 Stoppers	freeze dry stoppers injection stoppers
material
exact name and manufacturer of stoppers
	not known
stoppers are provided by the customer	yes no
8.3 Caps	Alu-cap Alu-cap with PE-disc
color
specific requirements
caps are provided by the customer	yes no
9. Final Packaging / Artwork bulk, without labeling bulk, with labeling ready-made packed
artwork / film is provided by the customer	yes no
9.1 Folding cartons
single folding carton vials / package folding carton/corrugated parts provided by the customer yes no
packaging with solvent	yes no
solvent provided by the customer	yes no
9.2 Labels
labels are provided by the customer	yes no
if known, text of the labels
10. Controls 10.1 In-process-controls Standard controls such as temperature, pH, filling amount, integrity of the filter, density, etc. are performed.
other IPC controls	yes no
if yes, which?
10.2 End controls
by Affinity GmbH	yes no
product specification available	yes no
control concerning sterility endotoxin (LAL) pyrogens (rabbit test) content HPLC purity HPLC	uniformity of the mass uniformity of the content water content content other methods purity other methods visible particles
other methods	yes no
if yes, please list
methods can be provided	yes no
reference substances supplied by the customer yes no
Stability tests to be performed	yes no
11. Specific Requests
storage of the final product in a cool place	yes no temparature ºC
protection from light	yes no
other requests
12. Additional Information