Standard Operating Procedure for Receiving of Raw Materials for Elixirs

1. Purpose

To define the procedure for the receipt and initial verification of raw materials intended for elixir manufacturing, ensuring that all materials received meet the specified quality standards and regulatory requirements before they are accepted into the warehouse or production.

2. Scope

This SOP applies to all raw materials, including active pharmaceutical ingredients (APIs), excipients, solvents, and packaging materials received for use in the Elixir Department.

3. Responsibilities

• Stores Officer:
  • Inspect delivery, check documentation, and coordinate with QA.
• Quality Assurance (QA):
  • Review documents, approve material movement to quarantine, and initiate sampling.
• Security Personnel:
  • Ensure only authorized vehicles and materials are allowed entry.

4. Accountability

The Head of QA is accountable for ensuring that all raw materials are received and processed as per this SOP and applicable GMP guidelines.

5. Procedure

5.1 Vehicle and Gate Entry

1. Security shall verify the gate pass, delivery challan, and vehicle credentials before entry.
2. Authorized vehicle shall proceed to the receiving bay at the designated area.

5.2 Preliminary Inspection by Stores

1. Check packaging condition, seal integrity, and labeling of all containers.
2. Ensure materials are not received during adverse weather without proper protection.
3. If damage or leakage is found, inform QA and quarantine the material separately.

5.3 Verification of Documents

1. Check the following documents accompanying the delivery:
   • Invoice
   • Certificate of Analysis (CoA)
   • Material Safety Data Sheet (MSDS)
   • Purchase Order (PO)
2. Ensure batch numbers and quantities match with the PO.

5.4 Unloading and Labeling

1. Unload the material manually or using a pallet truck/forklift as required.
2. Affix “UNDER TEST” status labels with receiving date, supplier name, batch number, and quantity.
3. Assign a unique material code and update the receiving register (Annexure-1).

5.5 Transfer to Quarantine Area

1. Move all received materials to the quarantine storage area under QA supervision.
2. Segregate APIs, excipients, and packaging materials in designated zones.

5.6 Intimation to QA for Sampling

1. Stores Officer shall intimate QA via Raw Material Sampling Request Form (Annexure-2).
2. QA shall perform sampling as per the sampling SOP and record details.

5.7 Entry in Receiving Logbook

1. Update the Receiving Logbook (Annexure-1) with the following:
   • Date and time of receipt
   • Material name and code
   • Quantity received
   • Supplier and transporter details
   • Remarks on condition

5.8 Handling of Rejected Materials

1. If QA identifies discrepancies or damage:
   • Affix “REJECTED” status label
   • Move material to rejected material storage
   • Update the rejection record (Annexure-3)

6. Abbreviations

• SOP: Standard Operating Procedure
• QA: Quality Assurance
• QC: Quality Control
• MSDS: Material Safety Data Sheet
• CoA: Certificate of Analysis
• PO: Purchase Order

7. Documents

1. Material Receiving Logbook (Annexure-1)
2. Sampling Request Form (Annexure-2)
3. Rejection Report Log (Annexure-3)

8. References

• WHO GMP Guidelines for Pharmaceutical Products
• 21 CFR Part 211 – cGMP for Finished Pharmaceuticals

9. SOP Version

Version: 2.0

10. Approval Section

11. Annexures

Annexure-1: Material Receiving Logbook

Annexure-2: Sampling Request Form

Annexure-3: Rejection Report Log

Revision History:

Standard Operating Procedure for Sampling of Raw Materials for Elixirs

1. Purpose

To lay down a procedure for the sampling of raw materials received for the manufacturing of elixirs, ensuring that the samples represent the entire consignment and are suitable for quality evaluation before approval for use.

2. Scope

This SOP applies to all APIs, excipients, and solvents received for elixir manufacturing in the Elixir Department and stored in the quarantine area before sampling and testing.

3. Responsibilities

• QA Personnel:
  • Perform sampling using the correct technique and sampling tools.
  • Ensure sample identity, integrity, and labeling.
• Warehouse Staff:
  • Arrange materials for sampling and ensure proper segregation.
• QC Analyst:
  • Receive and document samples for testing.

4. Accountability

The Head of Quality Assurance is accountable for the implementation and compliance of this SOP.

5. Procedure

5.1 Preparation for Sampling

1. Check availability of the following before sampling:
   • Sampling kit: sampling rods, triers, thief samplers
   • Sample containers (clean, inert, airtight)
   • Sterile gloves, masks, PPE, and gowning items
   • Sampling labels and forms
2. Verify environmental conditions of the sampling area:
   • Temperature and humidity should be within defined limits.
   • Area should be clean and sanitized before each sampling session.

5.2 Review of Documents

1. Collect and verify the following prior to sampling:
   • Purchase Order (PO)
   • Certificate of Analysis (CoA)
   • Material Receiving Checklist
2. Ensure each container is labeled with a unique identification number and “UNDER TEST” label.

5.3 Sampling Procedure

1. Randomly select containers as per the sampling plan:
   • √n + 1 sampling plan for ≤100 containers
   • For critical materials, 100% sampling may be performed
2. Open containers aseptically and collect required quantity from:
   • Top, middle, and bottom layers (for powders and granules)
   • Center (for liquids using dip rod or pipette)
3. Transfer samples to clean containers and label with:
   • Material name
   • Batch number
   • Date of sampling
   • Sampler’s initials

5.4 Sample Types and Quantity

1. Collect the following sample types:
   • Analytical Sample
   • Retain Sample (as per regulatory requirement)
   • Microbiological Sample (if applicable)
2. Sample quantity depends on the testing protocol and nature of material:
   • Solvents: 500 mL to 1 L
   • Excipients: 250 g to 500 g
   • APIs: 100 g to 250 g

5.5 Post Sampling Activities

1. Seal the sampled containers with “Sampled” sticker and sign/date it.
2. Close and secure remaining containers with tamper-evident seals.
3. Complete the Raw Material Sampling Record (Annexure-1).
4. Deliver samples to QC with proper documentation and sample receipt log (Annexure-2).

5.6 Handling of Atypical Observations

1. Report observations like:
   • Discoloration
   • Foul odor
   • Container damage
2. Segregate suspected containers and inform QA for further investigation.

6. Abbreviations

• SOP: Standard Operating Procedure
• QA: Quality Assurance
• QC: Quality Control
• CoA: Certificate of Analysis
• PPE: Personal Protective Equipment

7. Documents

1. Raw Material Sampling Record (Annexure-1)
2. Sample Receipt Log (Annexure-2)
3. Environmental Monitoring Log (if applicable)

8. References

• ICH Q7 – GMP for Active Pharmaceutical Ingredients
• 21 CFR Part 211 – Current Good Manufacturing Practice
• WHO Technical Report Series 1010

9. SOP Version

Version: 2.0

10. Approval Section

11. Annexures

Annexure-1: Raw Material Sampling Record

Annexure-2: Sample Receipt Log

Revision History:

Standard Operating Procedure for Storage of Raw Materials for Elixir Manufacturing

1. Purpose

To define the procedure for proper storage of raw materials including APIs, excipients, and solvents used in elixir manufacturing to maintain their quality, identity, strength, and purity throughout the storage duration.

2. Scope

This SOP is applicable to all raw materials received and intended for use in the Elixir Department, stored in designated warehouses under specified conditions until issuance for manufacturing.

3. Responsibilities

• Warehouse Staff:
  • Ensure proper storage conditions and segregation.
  • Monitor temperature and humidity.
  • Maintain storage records and inventory.
• Quality Assurance (QA):
  • Ensure compliance with storage SOP and approve material movement between areas.

4. Accountability

The Head of Warehouse and Head of QA are jointly accountable for adherence to this SOP and for the quality of stored materials.

5. Procedure

5.1 Warehouse Zoning

1. Divide the warehouse into the following designated zones:
   • Quarantine Area
   • Approved Material Storage
   • Rejected Material Area
   • Under Test Area
   • Controlled Substance Area (if applicable)
2. Clearly mark zones and maintain physical barriers as applicable.

5.2 Material Segregation

1. Store materials by category:
   • APIs separately from excipients and solvents
   • Hazardous materials in accordance with MSDS guidelines
   • Light-sensitive or humidity-sensitive materials in appropriate containers

5.3 Environmental Conditions

1. Monitor and record temperature and humidity twice daily using calibrated hygrometers and thermometers.
2. Standard storage conditions:
   • Ambient: 15°C to 25°C
   • Refrigerated: 2°C to 8°C (if applicable)
   • Humidity: Not more than 60% RH
3. Take corrective action if deviations occur and notify QA.

5.4 Material Storage Practice

1. Place materials on clean, labeled pallets—never directly on the floor.
2. Ensure labels face outward and are easily visible.
3. Use FIFO (First In, First Out) or FEFO (First Expiry, First Out) system as appropriate.
4. Affix status labels:
   • “Under Test” – Before QC release
   • “Approved” – After QC approval
   • “Rejected” – After QC rejection

5.5 Storage of Volatile and Flammable Materials

1. Store in flameproof cabinets or designated flameproof areas with ventilation.
2. Ensure fire extinguishers are available and inspected monthly.

5.6 Pest Control and Housekeeping

1. Conduct pest control activities monthly through authorized agencies.
2. Clean the warehouse floors, shelves, and surroundings daily using dry or damp mopping.
3. Spillages should be cleaned immediately and reported in the cleaning logbook.

5.7 Record Keeping

1. Maintain the following logs:
   • Material Location Log (Annexure-1)
   • Temperature and Humidity Log (Annexure-2)
   • Pest Control Log (Annexure-3)

6. Abbreviations

• SOP: Standard Operating Procedure
• QA: Quality Assurance
• API: Active Pharmaceutical Ingredient
• MSDS: Material Safety Data Sheet
• FIFO: First In, First Out
• FEFO: First Expiry, First Out

7. Documents

1. Material Location Log (Annexure-1)
2. Temperature and Humidity Log (Annexure-2)
3. Pest Control Log (Annexure-3)

8. References

• WHO GMP Guide – Storage of Pharmaceutical Products
• 21 CFR Part 211.80 – Storage and Distribution
• ICH Q7 – Good Manufacturing Practice for APIs

9. SOP Version

Version: 2.0

10. Approval Section

11. Annexures

Annexure-1: Material Location Log

Annexure-2: Temperature and Humidity Log

Annexure-3: Pest Control Log

Revision History:

Standard Operating Procedure for Issuance of Raw Materials for Elixir Production

1. Purpose

To describe the procedure for the controlled issuance of approved raw materials from the warehouse to the dispensing and manufacturing areas for the preparation of elixirs, ensuring traceability and compliance with GMP requirements.

2. Scope

This SOP applies to the issuance of all raw materials (APIs, excipients, and solvents) from the approved storage area of the Elixir Department for use in production batches of elixirs.

3. Responsibilities

• Warehouse Staff:
  • Verify availability and pick materials as per batch requisition.
  • Ensure only approved and released materials are issued.
• Production Supervisor:
  • Ensure materials received match the batch manufacturing record (BMR).
• QA Personnel:
  • Verify issuance process and perform line clearance where applicable.

4. Accountability

The Head of the Warehouse and Head of QA are accountable for ensuring the traceable and compliant issuance of raw materials for elixir production.

5. Procedure

5.1 Receipt of Requisition

1. The production department shall submit a Raw Material Requisition Form (Annexure-1) signed by the production supervisor and approved by the production head.
2. The warehouse officer shall check the requisition form for:
   • Batch number
   • Product name
   • Required material names, batch numbers, and quantities

5.2 Verification of Material Availability

1. Warehouse staff shall verify the availability of materials in the approved area against the requisition.
2. Materials nearing expiry or having special storage conditions must be flagged and managed accordingly.

5.3 Material Issuance

1. Pick only materials labeled “Approved” by QA and matching the requisition form.
2. Cross-verify:
   • Material Name and Code
   • Manufacturer/Supplier
   • Batch Number
   • Quantity Requested vs. Quantity Issued
   • Retest Date / Expiry Date
3. Transfer materials to the staging/dispensing area using clean and labeled trolleys or pallets.
4. Attach the Material Issue Label (Annexure-2) on each container issued.

5.4 Documentation and Recording

1. Record details in the Raw Material Issue Logbook (Annexure-3).
2. Warehouse staff shall sign and date the issue log and retain a copy of the requisition form.
3. Production staff shall verify and sign for receipt of materials.

5.5 Return of Excess Material

1. In case of over-issuance or cancellation, return of excess material must be documented using the Material Return Form (Annexure-4).
2. Returned material must be:
   • Checked for integrity and cleanliness
   • Labeled “Returned – Awaiting QA Decision”
   • Stored temporarily in the return area until QA decision

5.6 Issuance for Multiple Batches

1. Partial issuance of a single batch of material across multiple production batches must be properly recorded and reconciled.
2. Each issuance must include a unique entry in the logbook and reference the individual batch numbers.

5.7 Reconciliation and Verification

1. After dispensing, material reconciliation must be performed and confirmed by production and warehouse personnel.
2. Any discrepancies must be investigated and documented in the Material Reconciliation Sheet (Annexure-5).

6. Abbreviations

• SOP: Standard Operating Procedure
• QA: Quality Assurance
• BMR: Batch Manufacturing Record

7. Documents

1. Raw Material Requisition Form (Annexure-1)
2. Material Issue Label (Annexure-2)
3. Material Issue Logbook (Annexure-3)
4. Material Return Form (Annexure-4)
5. Material Reconciliation Sheet (Annexure-5)

8. References

• 21 CFR Part 211 – Subpart E: Control of Components
• WHO GMP Guidelines – Warehouse and Material Handling
• ICH Q7 – Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients

9. SOP Version

Version: 2.0

10. Approval Section

11. Annexures

Annexure-1: Raw Material Requisition Form

Annexure-2: Material Issue Label

Annexure-3: Material Issue Logbook

Annexure-4: Material Return Form

Annexure-5: Material Reconciliation Sheet

Revision History:

Standard Operating Procedure for Dispensing of Raw Materials for Elixirs

1. Purpose

To lay down the procedure for accurate and GMP-compliant dispensing of raw materials used in the manufacturing of elixirs to ensure correct quantities, avoid contamination, and maintain traceability.

2. Scope

This SOP applies to the dispensing of all raw materials including active pharmaceutical ingredients (APIs), excipients, and solvents used for manufacturing elixirs in the Elixir Department.

3. Responsibilities

• Warehouse Staff:
  • Perform material dispensing as per batch requirements.
  • Ensure accuracy in weighing and documentation.
• Production Supervisor:
  • Verify dispensed quantities and labels.
• QA Personnel:
  • Perform line clearance before dispensing.
  • Verify material identity, cleanliness of area, and labels.

4. Accountability

The Head of Warehouse and Head of Quality Assurance are accountable for ensuring that the dispensing activity is accurate, traceable, and performed in accordance with GMP.

5. Procedure

5.1 Pre-Dispensing Checks

1. Ensure dispensing area is cleaned and cleared by QA (line clearance checklist).
2. Confirm the weighing balance calibration status.
3. Review the batch manufacturing record (BMR) and material requisition form for:
   • Material Name and Code
   • Batch No.
   • Required Quantity
   • Storage Conditions

5.2 Material Selection

1. Select materials from the approved storage zone only.
2. Verify each container’s label for:
   • “Approved” status
   • Material name and code
   • Manufacturer/Supplier
   • Batch Number
   • Expiry/Re-test Date

5.3 Dispensing Activity

1. Use clean, pre-labeled dispensing containers with lids.
2. Place containers on the calibrated balance and tare the weight.
3. Weigh the required quantity as specified in the BMR using the correct balance (analytical for < 10g; precision for 10g–5kg; platform for >5kg).
4. Record the actual quantity weighed on the Material Dispensing Log (Annexure-1).
5. Affix the dispensing label (Annexure-2) with:
   • Material name and code
   • Batch No.
   • Quantity dispensed
   • Dispensing date
   • Signatures of operator and checker

5.4 Labeling and Segregation

1. Use color-coded labels (yellow for active, green for excipients, red for solvents).
2. Keep dispensed materials in segregated bins for each batch to avoid mix-ups.

5.5 Post-Dispensing

1. Return unused original containers to the approved storage area.
2. Label them as “Opened – In Use” with date of opening and initials.
3. Update the stock ledger with the new balance.
4. Ensure the weighing balance and dispensing platform are cleaned and recorded.

5.6 QA Verification

1. QA shall verify:
   • Correctness of material name and batch number
   • Quantity dispensed vs. BMR
   • Cleanliness of containers
   • Label accuracy
2. Sign off on the Material Dispensing Log.

6. Abbreviations

• SOP: Standard Operating Procedure
• QA: Quality Assurance
• BMR: Batch Manufacturing Record

7. Documents

1. Material Dispensing Log (Annexure-1)
2. Dispensing Label Format (Annexure-2)
3. Balance Calibration Record
4. Line Clearance Checklist

8. References

• 21 CFR Part 211 – Subpart E: Control of Components
• WHO GMP Guidelines – Section on Dispensing and Weighing
• ICH Q7 – Good Manufacturing Practice for Active Pharmaceutical Ingredients

9. SOP Version

Version: 2.0

10. Approval Section

11. Annexures

Annexure-1: Material Dispensing Log

Annexure-2: Dispensing Label

Revision History:

Standard Operating Procedure for Labeling of Raw Materials During Dispensing

1. Purpose

To define the procedure for proper and compliant labeling of raw materials at the time of dispensing for elixir manufacturing. This ensures traceability, prevents mix-ups, and supports GMP documentation practices.

2. Scope

This SOP applies to all raw materials, including active pharmaceutical ingredients (APIs), excipients, and solvents, that are dispensed for the manufacturing of elixirs in the Elixir Department.

3. Responsibilities

• Dispensing Operator:
  • Ensure all containers are labeled immediately after dispensing.
• Production Supervisor:
  • Verify correctness of label content and completeness.
• QA Personnel:
  • Review and approve dispensed material labels before use in production.

4. Accountability

The Head of Quality Assurance and Head of Warehouse are accountable for ensuring that all dispensed materials are labeled as per regulatory and internal GMP requirements.

5. Procedure

5.1 Label Format

1. Use standardized label format as per Annexure-1.
2. Labels must include the following information:
   • Material Name
   • Material Code
   • Batch Number of the Raw Material
   • Quantity Dispensed
   • Dispensed On (Date)
   • Dispensed By (Operator’s Name)
   • Checked By (Verifier’s Name)
   • Product Name & Batch Number for which the material is dispensed
   • Storage Condition (if applicable)

5.2 Label Types

1. Use different colored labels for different material types to minimize errors:
   • Yellow – APIs
   • Green – Excipients
   • Red – Solvents
2. Labels must be non-removable, waterproof, and legible.

5.3 Labeling Process

1. Prepare labels using designated labeling software or pre-approved templates.
2. After dispensing the material, affix the label to the dispensing container before transferring it to production.
3. Labels should be affixed directly on the container body, not on the lid.
4. In case of multiple containers for a single material, each container should be labeled individually.

5.4 Verification

1. The Production Supervisor shall verify:
   • Label content vs. batch records
   • Legibility and correctness of each label
2. QA shall cross-check a sample of labels daily to ensure GMP compliance.

5.5 Error Handling

1. If an error is identified:
   • Do not overwrite the label.
   • Affix a new correct label after striking off the incorrect one with a single line.
   • Sign and date the correction.
   • Document the incident in the Label Correction Log (Annexure-2).

5.6 Label Storage and Control

1. Blank labels must be stored in a secure, controlled area.
2. Maintain a log of label issuance and consumption.
3. Scrap unused or rejected labels with QA oversight.

6. Abbreviations

• SOP: Standard Operating Procedure
• QA: Quality Assurance
• GMP: Good Manufacturing Practice
• API: Active Pharmaceutical Ingredient

7. Documents

1. Dispensing Label Format (Annexure-1)
2. Label Correction Log (Annexure-2)
3. Label Issuance Logbook

8. References

• 21 CFR Part 211 – Labeling Requirements
• WHO GMP Guidelines – Materials Management

9. SOP Version

Version: 2.0

10. Approval Section

11. Annexures

Annexure-1: Dispensing Label Format

Annexure-2: Label Correction Log

Revision History:

Standard Operating Procedure for Environmental Conditions for Dispensing of Elixirs

1. Purpose

To define the environmental controls and conditions required during the dispensing of raw materials for elixir manufacturing to ensure product integrity, avoid contamination, and maintain regulatory compliance.

2. Scope

This SOP applies to all dispensing rooms and controlled areas where raw materials for elixirs are weighed, measured, or prepared prior to production within the Elixir Department.

3. Responsibilities

• Engineering Department:
  • Maintain HVAC systems and ensure environmental parameters are within specification.
• Warehouse Staff and Operators:
  • Work only within validated and clean areas.
  • Report any deviation in environmental conditions to QA and Engineering.
• Quality Assurance (QA):
  • Monitor environmental records and perform periodic audits.

4. Accountability

The Head of Engineering and the Head of QA are jointly accountable for ensuring that all dispensing activities are carried out under qualified and controlled environmental conditions.

5. Procedure

5.1 Environmental Specifications

1. The dispensing area must maintain:
   • Temperature: 18°C to 25°C
   • Relative Humidity (RH): Not more than 60%
   • Air Classification: ISO Class 8 or Grade D (EU GMP)
2. Air changes per hour (ACH) should be at least 20.
3. Differential pressure between adjoining areas: 10–15 Pascals.

5.2 Monitoring of Parameters

1. Temperature and RH shall be monitored and recorded twice daily on the Environmental Monitoring Log (Annexure-1).
2. In case of critical materials, continuous monitoring using data loggers is recommended.
3. Differential pressure should be recorded once per shift.

5.3 Cleaning and Sanitization of Dispensing Area

1. Daily cleaning must be performed before the start of dispensing activity:
   • Dusting of walls and equipment surfaces
   • Wet mopping of floors with approved disinfectant
2. Record cleaning activity in the Cleaning Logbook (Annexure-2).
3. Perform sanitization using disinfectants like IPA 70% weekly.

5.4 Access and Gowning Control

1. Only authorized personnel in cleanroom garments are allowed entry.
2. Gowning must be performed in gowning rooms adjacent to the dispensing area.
3. Use of masks, caps, gloves, and coveralls is mandatory.

5.5 Material and Equipment Control

1. All materials entering the area must be cleaned externally using IPA 70%.
2. Weighing balances and containers should be cleaned prior to use and stored in a covered manner when idle.

5.6 Alarm and Deviation Handling

1. If temperature or RH exceeds the permissible limit:
   • Stop dispensing activities.
   • Inform QA and Engineering immediately.
   • Investigate cause and document deviation.
2. Restart activity only after corrective action and QA approval.

5.7 Periodic Qualification and Maintenance

1. Dispensing area HVAC should undergo periodic qualification:
   • HEPA filter integrity: Semi-annually
   • Airflow visualization: Annually
2. Filters, air ducts, and grills should be cleaned as per the Preventive Maintenance Schedule.

6. Abbreviations

• SOP: Standard Operating Procedure
• RH: Relative Humidity
• ACH: Air Changes per Hour
• QA: Quality Assurance

7. Documents

1. Environmental Monitoring Log (Annexure-1)
2. Dispensing Area Cleaning Logbook (Annexure-2)
3. Deviation Report Form

8. References

• WHO GMP Guidelines for HVAC and Cleanroom Environments
• EU GMP Annex 1 – Manufacture of Sterile Medicinal Products
• 21 CFR Part 211 – Subpart D: Equipment and Facilities

9. SOP Version

Version: 2.0

10. Approval Section

11. Annexures

Annexure-1: Environmental Monitoring Log

Annexure-2: Dispensing Area Cleaning Logbook

Revision History:

Standard Operating Procedure for Cleaning of Dispensing Area Before and After Use

1. Purpose

To establish a standard procedure for the effective cleaning of the dispensing area before and after its use in order to maintain hygiene, avoid cross-contamination, and comply with GMP requirements during the preparation of materials for elixir manufacturing.

2. Scope

This SOP is applicable to all personnel involved in the cleaning and preparation of the dispensing area located within the Elixir Department. It includes procedures for cleaning prior to dispensing activity and post-use cleaning at the end of the activity or batch.

3. Responsibilities

• Warehouse Assistant:
  • Carry out cleaning activities using approved materials and procedures.
  • Document all cleaning in the Cleaning Logbook.
• Warehouse Supervisor:
  • Verify cleaning has been completed as per the SOP.
• QA Personnel:
  • Review and sign off line clearance and cleanliness prior to and after dispensing.

4. Accountability

The Head of Warehouse and the Head of Quality Assurance are accountable for ensuring proper implementation and documentation of cleaning procedures in the dispensing area.

5. Procedure

5.1 Cleaning Before Use

1. Ensure the area is free from any previous material residues or used equipment.
2. Clean the floor using a mop soaked in a freshly prepared solution of 0.5% Detergent followed by 70% IPA.
3. Wipe all working surfaces, equipment tables, and balance platforms using lint-free cloth and IPA 70%.
4. Clean weighing balances with a dry cloth followed by a cloth dipped in IPA 70%.
5. Use separate dedicated mops and cleaning cloths for the dispensing area only.
6. Allow surfaces to dry before beginning dispensing activity.
7. Record the activity in the Cleaning Logbook (Annexure-1).

5.2 Line Clearance

1. Inform QA to perform pre-use line clearance.
2. QA will verify:
   • Cleanliness of area and equipment
   • Absence of previous product traces or labels
3. QA to sign the Line Clearance Form (Annexure-2).

5.3 Cleaning After Use

1. Immediately after dispensing activity:
   • Remove all containers and equipment.
   • Wipe down all work surfaces with IPA 70%.
   • Clean floors with detergent solution followed by disinfection.
   • Remove and dispose of waste as per SOP for Waste Management.
2. Check for spills, powder dust, or any residual traces of the materials.
3. Complete and sign the post-use Cleaning Log.

5.4 Frequency of Cleaning

1. Before every dispensing activity (batch-wise).
2. After each dispensing activity.
3. Daily general cleaning at the end of shift.
4. Weekly deep cleaning including ceiling corners and grills.

5.5 Cleaning Material Management

1. Use approved cleaning agents only.
2. Label all cleaning equipment and store in dedicated cupboards.
3. Do not use cleaning tools from other departments in dispensing area.

6. Abbreviations

• SOP: Standard Operating Procedure
• QA: Quality Assurance
• IPA: Isopropyl Alcohol

7. Documents

1. Cleaning Logbook (Annexure-1)
2. Line Clearance Form (Annexure-2)

8. References

• 21 CFR Part 211 – Subpart D: Equipment and Facilities
• WHO GMP Guidelines – Pharmaceutical Production

9. SOP Version

Version: 2.0

10. Approval Section

11. Annexures

Annexure-1: Cleaning Logbook

Annexure-2: Line Clearance Form

Revision History:

Standard Operating Procedure for Line Clearance in Dispensing Area

1. Purpose

To establish a standard procedure for performing line clearance in the dispensing area to ensure that the area is free from any materials, products, documents, or equipment from the previous activity before initiating a new batch dispensing operation.

2. Scope

This SOP is applicable to all dispensing operations carried out in the designated dispensing area of the Elixir Department. It must be followed before the commencement of any new batch or material dispensing activity.

3. Responsibilities

• Warehouse Operator:
  • Perform preliminary check and inform QA for line clearance.
• QA Personnel:
  • Conduct line clearance inspection and authorize area readiness.
  • Ensure the area is free from materials/documents related to previous activities.
• Warehouse Supervisor:
  • Coordinate the line clearance activity and ensure compliance with this SOP.

4. Accountability

The Head of Quality Assurance is accountable for ensuring that line clearance is conducted as per procedure and documented prior to any dispensing activity.

5. Procedure

5.1 Pre-Line Clearance Checks

1. Ensure the area is cleaned and sanitized as per the cleaning SOP.
2. Verify that all equipment such as weighing balances, scoops, spatulas, and containers are cleaned and labeled “CLEANED.”
3. Check that no material, label, or document from the previous batch is present in the dispensing area.

5.2 QA Line Clearance

1. QA officer shall enter the dispensing area and perform the following verifications:
   • Cleanliness of floors, walls, and equipment surfaces
   • Availability of approved BMR and dispensing labels for the new batch
   • Absence of leftover raw materials, empty containers, or printed documents from the previous batch
   • Calibration status of weighing balances
   • Environmental parameters (temperature, RH, differential pressure)
2. Record all checks in the Line Clearance Checklist (Annexure-1).
3. If any discrepancy is observed, report immediately to the QA Manager and hold the activity until resolved.

5.3 Documentation

1. Complete the Line Clearance Checklist and affix it to the BMR.
2. QA personnel shall sign and date the checklist upon successful clearance.
3. Store the checklist with the batch documentation for future reference.

5.4 Re-Entry After Interruption

1. In case of power failure, equipment breakdown, or extended interruption during dispensing:
   • Repeat full line clearance before restarting the activity.
   • Record the interruption and re-clearance in the Remarks column of the checklist.

5.5 Line Clearance Frequency

1. Before the start of any batch dispensing.
2. After cleaning and sanitization of the dispensing area.
3. After any interruption, contamination event, or deviation.

6. Abbreviations

• SOP: Standard Operating Procedure
• BMR: Batch Manufacturing Record
• QA: Quality Assurance
• RH: Relative Humidity

7. Documents

1. Line Clearance Checklist (Annexure-1)

8. References

• WHO GMP Guidelines – Production and In-Process Controls
• 21 CFR Part 211 – Subpart F: Production and Process Controls

9. SOP Version

Version: 2.0

10. Approval Section

11. Annexures

Annexure-1: Line Clearance Checklist

Revision History:

Standard Operating Procedure for Use of Personal Protective Equipment (PPE) in Dispensing Room

1. Purpose

To establish standard requirements and procedures for the appropriate selection, usage, and disposal of personal protective equipment (PPE) by all personnel entering and working in the dispensing room of the Elixir Department.

2. Scope

This SOP applies to all employees, including permanent, temporary, and contract staff, involved in raw material dispensing activities for elixir manufacturing within the designated dispensing area.

3. Responsibilities

• All Dispensing Personnel:
  • Wear complete PPE before entering the dispensing room.
  • Follow gowning procedure as per training.
• Warehouse Supervisor:
  • Ensure availability and condition of PPE supplies.
• Quality Assurance (QA):
  • Conduct audits to verify compliance with PPE usage.

4. Accountability

The Head of Production and the Head of Quality Assurance are jointly accountable for enforcement and monitoring of PPE compliance in the dispensing room.

5. Procedure

5.1 PPE Requirements

1. The following PPE must be worn before entering the dispensing area:
   • Cleanroom coverall (non-shedding, full body)
   • Head cap
   • Face mask (surgical or N95, depending on sensitivity)
   • Sterile gloves (powder-free)
   • Shoe covers
   • Protective goggles (for handling potent or hazardous materials)
2. Use disposable PPE wherever applicable; discard after each shift or when soiled.

5.2 Gowning Procedure

1. Enter the change room adjacent to the dispensing room.
2. Wear garments in the following order:
   • Head cap
   • Face mask
   • Coverall suit
   • Shoe covers
   • Gloves
   • Goggles
3. Inspect PPE for damage or contamination before use.
4. Sanitize gloved hands using 70% IPA before entry.

5.3 Rules While Wearing PPE

1. Do not touch face or mask once PPE is worn.
2. Do not carry mobile phones, notebooks, or personal items inside the dispensing area.
3. Immediately replace PPE if it becomes torn, wet, or contaminated.

5.4 Exit Procedure

1. On completing dispensing activities:
   • Remove PPE in reverse order in the exit change room.
   • Discard disposable items in designated biohazard bins.
   • Place reusable PPE (if any) in the soiled garment bin for laundering.
2. Sanitize hands and sign the PPE Usage Log (Annexure-1).

5.5 Training and Compliance

1. All personnel must be trained on gowning procedure annually.
2. Gowning procedure posters should be displayed at entry points.
3. QA shall periodically verify PPE compliance and record observations.

6. Abbreviations

• SOP: Standard Operating Procedure
• PPE: Personal Protective Equipment
• IPA: Isopropyl Alcohol
• QA: Quality Assurance

7. Documents

1. PPE Usage Log (Annexure-1)
2. Training Record for PPE

8. References

• WHO GMP Guidelines – Personal Hygiene and Protective Equipment
• 21 CFR Part 211 – Subpart E: Control of Components and Drug Product Containers

9. SOP Version

Version: 2.0

10. Approval Section

11. Annexures

Annexure-1: PPE Usage Log

Revision History: