segregation and storage of acidic and alkaline raw materials. The QA Manager is responsible for verifying compliance with GMP and safety standards.

5. Procedure

5.1 Identification of Acidic and Alkaline Materials

1. Material Identification:
   • Identify acidic materials such as Hydrochloric Acid, Sulfuric Acid, and Citric Acid.
   • Identify alkaline materials such as Sodium Hydroxide, Potassium Hydroxide, and Calcium Hydroxide.
   • Verify classification using Safety Data Sheets (SDS) provided by suppliers.
   • Document identified materials in the Acidic and Alkaline Material Identification Log (Annexure-1).

5.2 Segregation and Storage Requirements

1. Storage Area Segregation:
   • Store acidic and alkaline materials in separate, clearly labeled storage areas.
   • Ensure a physical barrier or sufficient distance (minimum of 3 meters) between acidic and alkaline materials to prevent cross-contamination.
   • Document storage locations in the Acidic and Alkaline Material Storage Log (Annexure-2).
2. Environmental Controls:
   • Maintain temperature and humidity as specified in the SDS for each material.
   • Ensure proper ventilation in storage areas to prevent the accumulation of fumes.
   • Document environmental conditions in the Environmental Monitoring Log (Annexure-3).

5.3 Handling Procedures

1. Personal Protective Equipment (PPE):
   • Personnel must wear appropriate PPE, including chemical-resistant gloves, safety goggles, face shields, and lab coats.
   • For concentrated acids and bases, use additional respiratory protection as needed.
   • Document PPE usage in the PPE Compliance Log (Annexure-4).
2. Safe Handling Practices:
   • Handle acids and bases separately and never store or transport them together.
   • Use designated tools and containers for each type of material to avoid cross-contamination.
   • Document handling activities in the Material Handling Log (Annexure-5).

5.4 Spill and Emergency Procedures

1. Spill Containment:
   • For acid spills, neutralize with a suitable alkaline substance like sodium bicarbonate.
   • For alkali spills, neutralize with a weak acid such as citric acid.
   • Contain spills using non-reactive absorbent materials and dispose of as hazardous waste.
   • Document spill incidents in the Spill Incident Log (Annexure-6).
2. Emergency Response:
   • In case of accidental mixing of acids and bases, evacuate the area immediately due to the risk of violent reactions and gas release.
   • Use appropriate neutralizing agents and contact emergency services if necessary.
   • Document emergency responses in the Emergency Response Log (Annexure-7).

6. Abbreviations

• SOP: Standard Operating Procedure
• GMP: Good Manufacturing Practice
• QA: Quality Assurance
• PPE: Personal Protective Equipment
• SDS: Safety Data Sheet

7. Documents

1. Acidic and Alkaline Material Identification Log (Annexure-1)
2. Acidic and Alkaline Material Storage Log (Annexure-2)
3. Environmental Monitoring Log (Annexure-3)
4. PPE Compliance Log (Annexure-4)
5. Material Handling Log (Annexure-5)
6. Spill Incident Log (Annexure-6)
7. Emergency Response Log (Annexure-7)

8. References

• 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals
• OSHA Guidelines for Hazardous Chemical Storage (29 CFR 1910.106)
• WHO GMP Guidelines for Storage and Handling of Hazardous Materials

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Acidic and Alkaline Material Identification Log

Date	Material Name	Batch Number	Type (Acid/Alkali)	Identified By
15/03/2025	Hydrochloric Acid	HCL-1234	Acid	Ravi Kumar
15/03/2025	Sodium Hydroxide	NAOH-5678	Alkali	Neha Verma

Annexure-2: Acidic and Alkaline Material Storage Log

Date	Material Name	Batch Number	Storage Area	Storage Conditions	Stored By
15/03/2025	Hydrochloric Acid	HCL-1234	Acid Storage Room A1	Temperature: 22°C, Ventilated, Corrosion-resistant shelves	Ravi Kumar
15/03/2025	Sodium Hydroxide	NAOH-5678	Alkali Storage Room B2	Temperature: 20°C, Dry, Non-reactive containers	Neha Verma

Annexure-3: Environmental Monitoring Log

Date	Storage Area	Temperature (°C)	Humidity (%)	Status	Checked By
15/03/2025	Acid Storage Room A1	22°C	35%	Within Limits	Priya Singh
15/03/2025	Alkali Storage Room B2	20°C	30%	Within Limits	Amit Joshi

Annexure-4: PPE Compliance Log

Date	Employee Name	Material Handled	PPE Used	Compliance Status	Verified By
15/03/2025	Ravi Kumar	Hydrochloric Acid	Gloves, Goggles, Face Shield, Apron	Compliant	Neha Verma
15/03/2025	Amit Joshi	Sodium Hydroxide	Gloves, Goggles, Lab Coat	Compliant	Priya Singh

Annexure-5: Material Handling Log

Date	Material Name	Batch Number	Handling Procedure	Handled By	Verified By
15/03/2025	Hydrochloric Acid	HCL-1234	Transferred to smaller containers in fume hood	Ravi Kumar	Neha Verma
15/03/2025	Sodium Hydroxide	NAOH-5678	Weighed under dry conditions, sealed immediately	Amit Joshi	Priya Singh

Annexure-6: Spill Incident Log

Date	Material Name	Batch Number	Spill Description	Action Taken	Reported By
15/03/2025	Hydrochloric Acid	HCL-1234	Minor leak from container during transfer	Neutralized with sodium bicarbonate, cleaned with absorbent pads	Ravi Kumar
15/03/2025	Sodium Hydroxide	NAOH-5678	Spill during weighing process	Neutralized with citric acid solution, area rinsed and dried	Amit Joshi

Annexure-7: Emergency Response Log

Date	Incident Description	Immediate Response	Personnel Involved	Final Resolution	Verified By
15/03/2025	Accidental mixing of acid and alkali during transport	Evacuated area, used neutralizing agents, contacted emergency services	Neha Verma, Ravi Kumar	Area ventilated, materials disposed of as hazardous waste	Priya Singh
15/03/2025	Fume build-up in acid storage room	Activated ventilation system, evacuated non-essential personnel	Amit Joshi	Fumes dispersed, storage conditions adjusted	Neha Verma

Revision History:

Revision Date	Revision No.	Revision Details	Reason for Revision	Approved By
01/01/2024	1.0	Initial Version	New SOP Implementation	QA Head
15/03/2025	2.0	Updated segregation and emergency response protocols	Alignment with revised GMP and safety guidelines	QA Head