지식 베이스

What evidence to ask for, what a certificate can and cannot prove, and how to turn the answers into a documented approve, conditionally approve or reject decision.

What FDA's QMSR and ISO 13485 Clause 7.3 design controls require across the device development process.

What a retained/reserve sample program must maintain and for how long, by product type.

How 21 CFR Parts 210 and 211 are organized and what each subpart addresses.

Where 3D printing is genuinely being used in pharma manufacturing today, and where it remains limited.

What an ANDA submission needs to include, and the deficiencies FDA cites most often.

How accelerated conditions are used to predict shelf life and where the approach has limits.

How airlocks are designed to control contamination risk for personnel and material entry into aseptic areas.

Trade-offs between amorphous and crystalline API forms for solubility, stability, and manufacturability.

How laboratory analysts are trained and assessed as competent before performing GMP testing independently.

The validation parameters ICH Q2(R2) expects — accuracy, precision, specificity, and more — and how they connect.

How robustness testing evaluates whether small deliberate method changes affect results.