SR. NO.
Question
3.0 Warehousing & Storage Yes No NA
3.1
Do you have segregated areas for Starting material, Packing Materials, Semi-finished
3.2
Are storage conditions (temperature & humidity) controlled and regulated?
3.3
Do you have pest Control and sanitation procedure for your Warehouse?
3.4
Which of the following principle is applied in storage operation (FEFO/ FIFO)?
4.0 Facility & Production Yes No NA
4.1
Are any of the following procedure at the same site ?
4.2
Is the equipment:
› dedicated › multipurpose
4.3
Are critical parameters of the process identified?
4.4
Have you validated ›production processes ›cleaning processes
4.5
Is your Air Handling system qualified and pressure differentials monitored ?
4.6
What type of water do you use in production?
4.7
Is your water system validated?
5.0 Quality control & Quality Assurance Yes No NA
5.1
Is QA an independent department?
5.2
Do you have a Site Master File & Validation Master Plan in Place?
5.3
Is there a list of approved supplier for :
1
All materials used in the production and all services that affect product quality
2
All starting and packing material
3
Critical material only
5.4
Is sampling performed by QC done for
1
Starting and packing materials
2
Intermediates
3
Semi- finished and finished products
5.5
Are Starting and packing materials accepted on the basis of
1
in-coming analysis
2
supplier's analytical certificate
If on the basis of suppliers analytical certificate, how is the suppliers controlled ?
5.6
Is Sampling performed according to the sampling plan ?
5.7
Do you analyze every batch of the products ?
5.8
Are the analytical tests performed in-house ?
5.9
Do you store your control sample ?
5.10
Do you carry out stability studies at your end ?
5.11
Do you characterize all the impurities ?
5.12
Do you review all the batch documents before release of the products ?
6.0 Packaging and Dispatch Yes No NA
6.1
What are your standard pack sizes ?
6.2
What is your standard packing ?
6.3
Can you adjust your packing size to our requirement ?
6.4
Do you have your own transport for delivery of the products to the customers ?
6.5
How do you transport the materials requiring special storage condition?
6.6
Do you use the re-usable packaging material?
6.7
How do you ensure cleaning of the re-usable packaging material?
6.8
Do you provide certificate of analysis with every batch of material?
7.0 Regulatory Compliance ( If applicable)
7.1
To which market do you delivered your products?
7.2
Are you a Certificate of suitability (COS) holder?
7.3
Was FDCA 483 issued to you?
7.4
What products were inspected?
7.5
Do you use any starting or raw material of biological or animal origin?
