Establish the current approved record
Keep supplier and contracting identity, code, form, relevant specification, preparation instruction and accepted feed range. Identify which revision the previous purchase actually used.
If historical information is incomplete, mark the uncertainty and reconstruct the essential evidence. Do not turn an old invoice description into a technical specification without checking what it represented.
Request a clear change description
Ask what changed, why, when it takes effect and which lots or documents are affected. Relevant changes can include code, manufacturing arrangement, release method, commercial form, packaging or preparation instructions.
A statement that the product is equivalent needs supporting detail. A renamed code may be administrative, but purchasing should not assume that every renaming is purely administrative.
Choose the appropriate review
Have the responsible technical team decide whether document alignment, retained-sample comparison, preparation testing or plant requalification is needed. Match the evidence to the possible effect on the process.
Keep analytical identity and application performance separate. A matching COA value may not resolve a changed preparation behavior or the consequences of a different particle or molecular profile.
Control the transition
Identify old and new stock, preserve suitable benchmark material and avoid an unrecorded mixture during evaluation. Keep a rollback plan where production risk warrants it.
The batch and change-control checklist links receiving decisions to qualified conditions. Record feed and equipment changes at the same time so a product review does not assign unrelated process variation to the supplier.
A repeat-order authorization
Write the review outcome, supporting evidence, accepted code and effective shipment. Keep any limitation or temporary concession visible rather than removing the previous specification without explanation.
Use the PAM change-review enquiry with the last accepted record and proposed revision. Continue supply only under the agreed approval boundary; prior successful deliveries do not automatically authorize every future substitute or manufacturing arrangement.
Change review evidence
| Checkpoint | Evidence to retain | Decision boundary |
|---|---|---|
| Scope | Request what changed, why, effective code or batch and the affected methods, preparation or package records. | A renamed code should not be assumed administrative without checking the actual change. |
| Assessment | Identify the responsible technical decision and whether document, preparation or plant evidence is needed. | Matching one analytical value does not establish unchanged molecular behavior, distribution or process performance. |
| Transition | Keep old and proposed stock identifiable, with approved limits and any temporary concession recorded. | An undocumented mixture or silent replacement makes later comparisons difficult and must not become routine substitution permission. |