Hardgel Capsules Qualifications plays important role in pharma. Hardgel Capsules are solid dose forms that contain one or more active ingredients and/or inert fillers inside of a tiny shell. They are mostly made of gelatin and have two parts: a body that is intended to hold the medication and diluent and a cap that is roughly half as long as the body. In addition to gelatin, it may also include additives including plasticizers, colorants, opacifying agents, and preservatives that either facilitate the creation of capsules or enhance their functionality. In addition, 12–16% of Hardgel capsules are made of water.
- Design Qualification of Softgel Encapsulation Machine
- Installation Qualification for Capsule Filling Machine
- Operational Qualification for Capsule Filling machine
- Performance Qualification Protocol for Capsule Filling Machine
- Design Qualification for Automatic Capsule Filling Machine with Powder, Pellet and Tablet Filling Attachment
- Installation Qualification for Automatic Capsule Filling Machine with Powder, Pellet and Tablet Filling attachment
- Operational Qualification for Automatic Capsule Filling Machine with Powder, Pellet and Tablet Filling Attachment
- Design Qualification for Automatic Capsule Filling Machine
- Installation Qualification for Automatic Capsule Filling Machine
- Operational Qualification for Automatic Capsule Filling Machine
- Performance Qualification Protocol for Automatic Capsule Filling Machine
- Design Qualification for Capsule Polishing Machine & Unfilled Capsule Separator
- Installation Qualification for Capsule Polishing Machine & Unfilled Capsule Separator
- Operational Qualification for Capsule Polishing Machine & Unfilled Capsule Separator
- Design Qualification for Empty Capsule Sorter Elevator
- Installation Qualification for Empty Capsule Sorter Elevator
- Operational Qualification for Empty Capsule Sorter Elevator
- Design Qualification for Filled Capsule Sorter with Mini Capsule Sorter
- Installation Qualification for Filled Capsule Sorter with Mini Capsule Sorter
- Operational Qualification for Filled Capsule Sorter with Mini Capsule Sorter
STANDARD OPERATING PROCEDURE
- SOP for Issuance and Retrieval of Change Parts for Hard Gelatin Capsule Filling Machine
- SOP for Operation and Cleaning for Capsule Polishing Machine
- SOP for Operation and Cleaning of Automatic AF 150 Capsule Filling Machine
- SOP for Operation and Cleaning of Automatic Capsule Filling Machine (A-60) and its accessories
- SOP for Operation and Cleaning of Automatic Capsule Filling Machine (A-120) and its Accessories
- SOP for Operation and Cleaning of Semiautomatic Capsule Filling Machine
- SOP for Operation and Cleaning of Roto Cube Mixer
QUESTIONS AND ANSWERS
1. What is equipment qualification in the context of Hardgel manufacturing?
Answer:
Equipment qualification is the documented process of verifying that the equipment used in Hardgel capsule manufacturing is designed, installed, operated, and performs as intended. This ensures consistent production of capsules within defined quality parameters and complies with GMP guidelines.
2. What are the key stages of equipment qualification?
Answer:
The main stages are:
- Design Qualification (DQ) – Verifies design meets process and regulatory needs
- Installation Qualification (IQ) – Confirms equipment is installed correctly per design
- Operational Qualification (OQ) – Tests equipment functionality under expected conditions
- Performance Qualification (PQ) – Verifies performance under real manufacturing conditions with actual product or placebo
3. Which equipment is typically qualified in Hardgel capsule production?
Answer:
Key equipment includes:
- Capsule filling machine (e.g., Bosch, ACG)
- Capsule polishing machine
- Capsule inspection belt
- Capsule sorting equipment (length/weight)
- Dehumidifier/HVAC for encapsulation room
- Granulator and mixer (for filling blend)
4. What are critical parameters during qualification of a capsule filling machine?
Answer:
Critical parameters include:
- Dosage weight consistency
- Machine speed (capsules per minute)
- Tamping pin settings
- Vacuum pressure for capsule separation
- Capsule orientation and lock efficiency
- Reject mechanism function
5. How is the Operational Qualification (OQ) conducted for capsule equipment?
Answer:
OQ is conducted by running the equipment under defined conditions (idle and simulated load) to verify:
- Alarm functions
- Display and controls
- Safety interlocks
- Calibration of sensors and load cells
- Repeatability and accuracy of settings
Results are documented in OQ protocols with predefined acceptance criteria.
6. How do you perform Performance Qualification (PQ) on a capsule filler?
Answer:
PQ involves running production batches (usually 3 consecutive lots) under normal operating conditions with actual product or placebo. Key outputs include:
- Capsule weight uniformity
- Capsule integrity
- Machine downtime and reject rates
- Operator intervention
All results must meet batch record and regulatory acceptance criteria.
7. What documents are required for Hardgel equipment qualification?
Answer:
Essential documents include:
- User Requirement Specification (URS)
- Qualification Protocols and Reports (DQ, IQ, OQ, PQ)
- Calibration records
- Change control forms
- Maintenance logs
- Equipment manuals and P&ID diagrams
8. What regulatory guidelines govern equipment qualification?
Answer:
Relevant guidelines include:
- EU GMP Annex 15 – Qualification and Validation
- US FDA Process Validation Guidance
- ICH Q8, Q9, Q10 – Process Design, Risk Management, and Quality Systems
9. What risks are considered during equipment qualification for capsules?
Answer:
Risks include:
- Inconsistent fill weight
- Improper capsule sealing
- Cross-contamination
- Machine failure or alarms not functioning
- Material hold-up in hoppers or transfer lines
10. Why is requalification important?
Answer:
Requalification ensures equipment continues to operate within validated parameters over time. It is necessary after major maintenance, change in use, relocation, or periodically as defined in SOPs.
Excellent Documents and the content of the it, i would like to follow this more in my daily use.
Could you please guide me how can I Download the documents.
Dear leave your mobile number