1. IQ for Automatic Rotary Vacuumetric Dry Syrup Filling with ROPP Capping Machine
2. OQ for Automatic Rotary Vacuumetric Dry Syrup Filling with ROPP Capping Machine
3. IQ for Automatic Airjet Bottle Cleaning Machine
4. OQ Automatic Airjet Bottle Cleaning Machine
5. IQ for Induction Sealing Machine
6. OQ for Induction Sealing Machine
7. IQ for Automatic Cup Placement
8. OQ for Automatic Cup Placement
9. IQ for Automatic Vertical Round Bottle Sticker Labelling Machine
10. OQ for Automatic Vertical Round Bottle Sticker Labelling Machine

Dry powder for oral suspension (often called dry syrup) is a solid mixture that is reconstituted with water before use. It is widely used for paediatric and geriatric patients who cannot swallow tablets or capsules and often contains antibiotics or other sensitive drugs.

From a GMP perspective, qualification of dry powder for oral suspension covers the formulation, manufacturing process, reconstitution performance and finished product quality. Development focuses on selecting suitable excipients (suspending agents, sweeteners, buffers, wetting agents, flavours and preservatives) to give a stable, easily redispersible suspension with acceptable taste after reconstitution.

Regulatory guidance such as ICH Q6A highlights specific attributes for dry powders that require reconstitution. Specifications usually include reconstitution time with a defined acceptance limit and a justified choice of diluent, water content, and, where relevant, dissolution or particle size distribution to ensure consistent drug release. ICH Database+1

During manufacturing, in-process control (IPQC) checks the uniformity and quality of the blend and granules. For suspensions, typical tests include appearance, particle size, drug content uniformity and redispersibility to minimise variability before final filling.

Finished product qualification confirms that every batch meets its critical quality attributes:

• Assay and content uniformity of the active
• Moisture content and microbial limits
• Flow properties and fill weight accuracy
• Reconstitution volume and time
• Sedimentation behaviour, redispersibility, viscosity and pH after reconstitution
• Palatability and appearance of the suspension
• Stability under ICH conditions in both dry and reconstituted forms.

Robust aerosols… (no) – we’re on suspensions.

Robust qualification and validation of dry powder for oral suspension show regulators that the product can be stored, reconstituted and administered safely throughout its shelf-life, while delivering a reproducible dose to some of the most vulnerable patient groups.