The SOP for Entry and Exit Procedure for Grade C Area in an injectable pharmaceutical manufacturing plant is of paramount importance for ensuring the safety, quality, and integrity of the products being produced. Here are some key reasons why this procedure is crucial:
- Contamination Control: Grade C areas in pharmaceutical manufacturing are critical zones where sterile products are prepared and processed. Proper entry and exit procedures help prevent contamination of these areas by ensuring that only authorized personnel with appropriate protective gear enter the space.
- Product Quality: Maintaining the quality of injectable pharmaceuticals is essential to ensure that they are safe and effective for patients. Entry and exit procedures help minimize the risk of contamination, which can compromise product quality.
- Compliance with Regulations: Regulatory authorities such as the FDA (U.S. Food and Drug Administration) and EMA (European Medicines Agency) have strict guidelines for pharmaceutical manufacturing facilities. Adhering to proper entry and exit procedures is essential for compliance with these regulations.
- Employee Safety: Grade C areas may involve exposure to hazardous substances and potentially infectious materials. Implementing clear entry and exit procedures helps protect the safety and health of employees by ensuring they follow safety protocols and use appropriate personal protective equipment (PPE).
- Chain of Custody: In pharmaceutical manufacturing, it’s cr
- ucial to maintain a clear chain of custody for raw materials, intermediates, and finished products. Entry and exit procedures help track who enters and leaves these critical areas, enhancing accountability in the manufacturing process.
- Security: Pharmaceutical manufacturing plants handle valuable and sensitive materials. Controlling access to Grade C areas through strict entry and exit procedures helps prevent unauthorized personnel from accessing critical areas, reducing the risk of theft or tampering.
- Environmental Control: Grade C areas often require precise environmental conditions, including temperature and humidity control. Entry and exit procedures help ensure that these conditions are maintained consistently, contributing to product stability and quality.
- Documentation and Record-Keeping: Proper entry and exit procedures require personnel to log their activities, including the purpose of entry, time spent inside Grade C areas, and any actions taken. This documentation is vital for audits and investigations.
- Emergency Response: In the event of an emergency or contamination incident, well-defined entry and exit procedures ensure that personnel can quickly evacuate or respond to the situation while minimizing the risk of spreading contamination.
- Training and Education: Implementing strict entry and exit
procedures necessitates training and education of all personnel involved. This enhances their understanding of the importance of maintaining clean, controlled environments and adhering to safety protocols.
In conclusion, the Entry and Exit Procedure for Grade C Areas in an injectable pharmaceutical manufacturing plant is a critical component of ensuring product quality, employee safety, regulatory compliance, and overall pharmaceutical manufacturing integrity. Strict adherence to these procedures helps maintain the highest standards of pharmaceutical production and ultimately safeguards the health of patients who rely on these medications.
SOP for Entry and Exit Procedure for Grade C Area
- OBJECTIVE:
- To lay down a written procedure for entry and exit in the Class C area of the production department.
- OBJECTIVE:
- SCOPE:
- This SOP is applicable to all personnel entering into the Class C area of the production department.
- SCOPE:
- RESPONSIBILITY:
- All the personnel entering and leaving the Class C area of the production department.
- RESPONSIBILITY:
- ACCOUNTABILITY:
- Head/ designee – Quality and Production shall be accountable for the SOP.
- ACCOUNTABILITY:
- DEFINITIONS:
- Nil.
- DEFINITIONS:
- PROCEDURE:
- Precautions:
- Do not walk rapidly and fast inside the area.
- Follow the procedure for Entry / Exit as per photographs present in the changing room.
- At the time of entering, ensure Differential pressure of each room is OK.
- There should be no tear and bear on garments.
- Ensure that contact time of NLT 1 minute has been provided after each gloved hand/surface sanitization activity.
- Precautions:
- Note:- Before entry to Grade C area personnel shall record their health and hygiene details in format.
- Entry Procedure for Male:
- Scan your appropriate finger over the biometric system.
- Open the door with Elbow to enter in to the Change Room 1 of Grade C area.
- Place the factory shoes into the provided shoe cabinet.
- Remove CNC garments sequentially.
- Keep the garments in cabinet provided.
- Sanitize hands up to elbow with 70% v/v IPA/Sterilium provided.
- Entry Procedure for Male:
- Note:-After hand sanitization activity, allow contact hold time for NLT 1 minute.
- Open the garment cabinet and take clean set of innerwear garments.
- Transfer the garment cover in disposal bin.
- Wear the innerwear hood and ensure that all hairs are well tucked in hood.
- Wear the innerwear Gown.
- Wear the innerwear trouser with bootie.
- Check the adequacy of attire in mirror.
- Press the interlock button.
- Push the door with elbow and enter in change room 2.
- Take the wrist size gloves from gloves box and wear the gloves.
- Sanitize gloved hands with 70% v/v IPA/Sterilium provided.
- Note: After hand sanitization activity, allow contact hold time for NLT 1 minute.
- Take a set of grade C garments.
- Transfer the garment cover in used garment bin.
- Wear the Grade C hood.
- Wear the Grade C gown.
- Wear the Grade C booties.
- Collect second pair of elbow size gloves from gloves box.
- Wear elbow size gloves and tuck in the sleeves.
- Sanitize gloved hands up to elbow with 70% v/v IPA/Sterilium provided.
- Stand in front of the mirror and check the attire.
- Press the interlock button and open the door with elbow to enter the Grade C corridor.
- Note:-After hand sanitization activity, allow contact hold time for NLT 1 minute.
- Exit Procedure For Male:
- Press the door interlock button.
- Pull the door with wrist to enter change room 2.
- Remove the elbow size gloves and place in disposal bin.
- Remove the Grade C booties.
- Transfer the booties in used garment cabinet.
- Remove the Grade C Gown.
- Transfer the gown in used garment cabinet.
- Remove the Grade C hood.
- Transfer the hood in used garment cabinet.
- Remove the wrist size gloves and place in disposal bin.
- Push the door interlock button.
- Pull the door with wrist and open the door to enter change room 1.
- Remove the inner trouser.
- Transfer the innerwear trouser in used garment cabinet.
- Remove the innerwear gown.
- Transfer the innerwear in used garment cabinet.
- Remove the innerwear hood.
- Transfer the innerwear hood in used garment cabinet.
- Take the CNC garments from cabinet.
- Wear the CNC hood.
- Wear the CNC garments sequentially.
- Collect the factory shoes from cabinet and then wear the factory shoes one by one.
- Sanitize hands with 70% v/v IPA/Sterilium provided.
- Stand in front of the mirror and check the attire.
- Press the door interlock button.
- Pull the door with wrist to enter CNC corridor
- Exit Procedure For Male:
- Entry Procedure for Female / Visitor:
- Female / Visitor enter inside grade C area through Female / Visitor Change room.
- Note: Entry of any visitor is allowed to Grade C area in presence of any authorized person only.
- Accompanying authorized person shall follow the procedure mentioned above.
- Remove the visitor dress and keep the garments in cabinet provided.
- Follow the entrance procedure as mentioned above..
- Entry Procedure for Female / Visitor:
- Exit Procedure For Female / Visitor:
- Female / Visitor exit from grade C area through Female / Visitor Change room.
- Follow the exit procedure mentioned above.
- Collect the visitor dress from the cabinet and then wear the visitor dress.
- Follow the gowning procedure as mentioned above.
- Follow the procedure for Entry/Exit as per photographs present in the change rooms (Refer Appendix- SOP/PR/XXXYYY, Appendix-SOP/PR/XXXYYY, Appendix –SOP/PR/XXXYYY and Appendix –SOP/PR/XXXYYY).
- Exit Procedure For Female / Visitor:
- ABBREVIATIONS:
- SOP : Standard Operating Procedure
- Pvt. : Private
- Ltd. : Limited
- No. : Number
- % : Percentage
- v/v : Volume by volume
- CNC : Controlled Not Classified
- IPA : Iso Propyl alcohol
- ABBREVIATIONS:
- REFERENCES:
- SOP/QC/XXXYYY
- SOP/PR/XXXYYY
- REFERENCES:
- DISTRIBUTION LIST:
- Control copy of SOP shall be distributed to Quality Assurance and Production departments.
- DISTRIBUTION LIST:
- ANNEXURES:
- Entry procedure for Grade C Area (Staff) : SOP/PR/XXXYYY
- Exit procedure for Grade C Area (Staff) : SOP/PR/XXXYYY
- Entry Procedure For Grade C area (Visitor) : SOP/PR/XXXYYY
- Exit Procedure For Grade C area (Visitor) : SOP/PR/XXXYYY
- Personnel Health and Hygiene Record : SOP/PR/XXXYYY
- ANNEXURES:
PERSONNEL HEALTH AND HYGIENE RECORD
| Sr. No. | Date | Shift | Emp. Name | Emp. Code | Department | Physical injury/ Open lesion/ Allergic reaction | Clean Shaved | Trimmed Nails | Trimmed Hair | Ornaments | Others (If any) | Self-assessment (Sign & date) | Remarks (If Any): |
