How do you conduct acceptance tests for bulk drugs?
Way of thinking：When accepting bulks, we check the COAs, package appearance and labeling.
Customers are kindly requested to attach their the COA. At the customer’s request,we can do specification tests.
Costs：Manufacturing costs include the costs of package appearance and labeling. Costs of specification tests are estimated on the basis of man-hours involved.
Do you procure auxiliary materials and raw materials?
Way of thinking：Basically, customers are requested to procure them and forward them to us with their COAs, based on which we perform the acceptance test. If you want us to prepare for them, the specifications of the acceptance test will be decided after mutual discussions, provided that, however, test requirements that might affect product quality are mandatory for both auxiliary materials and raw materials.
Costs：For auxiliary materials and raw materials of our procurement, we charge at costs. Manufacturing costs include the costs of checking COAs, package appearance and labeling. Costs of specification tests are estimated on the basis of man-hours involved.
What kind of water do you use for injection?
Way of thinking：We use self-manufactured, specially-distilled water for injection manufacturing. The distilled water for injection is tested in terms of requirements for “Water for Injection” in the Japanese Pharmacopeia. At a customer’s request, we can do US and European Pharmacopoeia compliant tests.
Costs：The costs are included in manufacturing costs.
How often do you perform validation?
Way of thinking：We conduct validation (including media fill tests) on a regular basis. Upon customer’s request, we compile and submit a list of what was validated and the validation results.
Costs：Total costs incurred over a year divided by 42 (weeks) x the number of weeks when the clean room was occupied for manufacturing
Way of thinking：When the customer believes that items other than those included in our regular validation need to be validated, we perform the validation in accordance with a validation plan formulated based on the outcome of discussions with the customer and issue a validation report. At the customer’s request, we conduct medium filling tests after discussing scale and number of lots with the customer.
Costs：The costs are estimated based on man-hours of each item.
Tell us about contract manufacturing.
Way of thinking：Usually, we perform test production; however, it may be omitted if it involves standard operations only. Some customers see test production as the equivalent to manufacturing validation.
Costs：The costs are estimated based on man-hours of each item.
Master Batch Record and Production Direction/Production Record
Way of thinking：A draft of Master Batch Record is prepared, which describes all the things we do from bulk acceptance to manufacturing, packaging and release of the products. After the customer’s review of the drafts, the approval process proceeds in accordance with the “Master Batch Record Control” of our GMP (TP-GMP). A draft of “Production Direction/Production Record” is also prepared. The approval process of the form is decided after consultation with the custmer. When any chance is made after manufacturing starts, the draft of the revised from is prepared after consultation with the customer. After agreement by both parties, the revision process is completed according to the above procedure.
Costs：For the preparation of Master Batch Record and Production Direction/Production Record, costs are estimated based on man-hours. Costs for correction of these documents, mainly on PC, are added when it is necessary to redo the documents due to mistaken preparation standards or recycle documents used for manufacturing of similar items.
Observation during manufacturing
Way of thinking：The customer is kindly requested to observe critical processes, especially the processes of dispensing/preparation and filling of drug solutions. However, this is not the case when test production or validations are conducted prior to manufacturing.
What do you do for product release?
Way of thinking：Three options are available. a. All the requirements in the specification tests: In this case, the customer is kindly requested to transfer technology for the specification tests to us. Our product security pharmacist for drug product or IND will issue a release permission based on the results of the specification tests conducted by us. b. Selected requirements in the specification tests only (appearance, content, etc. Other requirements are checked by the customer.): Prior to release, samples will be taken from products and forwarded to the customer for specification tests. The customer is kindly requested to transfer technology for the key requirements in the specification tests. Our product security pharmacist for drug product or IND will issue a release permission based on either: 1. results of specification tests by the customer and the results of the specification tests by us; or 2. results of specification tests in terms of the key requirements by us.
----> In the latter case, the customer will not receive samples. c. Appearance inspection (as part of in-process inspection) only: In this case, the customer checks all the requirements in specification tests. Prior to shipment, samples will be taken from products and forwarded to the customer for specification tests.
----> Our product security pharmacist for drug produt or IND will issue a release permission based on the results of the specification tests by the customer.
Costs：Differ among the three options. a. Technical transfer fee, validation fee and a specification test performance fee for the requirements in specification tests checked by us are charged. b. Same as above. c. Technical transfer fee validation fee as well as a specification test performance fee are not charged. Costs are estimated based on man-hours of each test requirement.
Way of thinking：Shipping conditions (transportation temperature, carrier, etc.) are agreed between the customer and us. When the customer deems necessary, transportation validation will be performed.
Costs：Transportation of products will be charged at cost. The manufacturing costs include those for validating transportation, but the transportation of products for validation will be charged at cost.
Tell us about your packaging services.
Way of thinking：Specifications for labeling and packaging are decided after consultation with the customer. The detailed procedures are described in the Master Batch Record.
At the request of the customer, we will arrange labels and boxes.
Costs：The costs are estimated based on man-hours of each job. Materials arranged by us will be charged at cost.
Tell us about your cleaning validation services.
Way of thinking：Two options are available depending on whether the technology transfer of analytical methods for API has been done to us or not. a. Transferred：Sampling from the inner surface of the container is conducted in accordance with our SOP. Analysis is done in accordance with the transferred technology. b. Not transferred：Sampling from the inner surface of the container is conducted in accordance with our SOP or the customer’s SOP. Analysis is done by the customer.
Costs： a. The costs are estimated based on man-hours. b. The manufacturing costs include sampling costs.
Can we have any remaining raw materials back?
Way of thinking：At the request of the customer, any remaining raw materials will be returned on a date mutually agreed.
Costs：Transportation costs will be charged at cost.