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Regulatory Control of Tablets and Capsules:
Pharmacopeial Standards:

• BP, USP, Ph.Eur. define tests for:
o Identification.
o Assay.
o Content uniformity.
o Dissolution.
o Disintegration.
o Friability.

Regulatory Agencies:
• FDA (USA), EMA (Europe), MHRA (UK), Egyptian Drug Authority (EDA).

Quality by Design (QbD):
Systematic approach to pharmaceutical development emphasizing understanding and control.
Elements:

1. Target Product Profile (TPP): defines desired quality and performance.
2. Critical Quality Attributes (CQAs): tablet hardness, dissolution, assay, etc.
3. Critical Process Parameters (CPPs): blending time, compression force.
4. Design Space: range of parameters assuring quality.
5. Control Strategy: in-process and final tests.

Examples of CQAs for Tablets:

Attribute Target Impact

Hardness 5–8 kg Disintegration/dissolution

Thickness ±5 % Appearance, packaging

Friability <1 % Mechanical stability

Disintegration ≤15 min Bioavailability

Assay 95–105 % Potency

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