2. Scope
The scope of this procedure covers all the raw materials that are used in the manufacturing of products at the facility. This procedure is applicable to all the departments involved in raw material procurement, storage, testing, and usage.

3. Procedure
The Raw Material Change Control Procedure is to be followed in the following steps:

Step 1: Change Request
Upon identification of a need to change a raw material specification or supplier, the concerned department personnel should complete the Raw Material Change Request form. This form should contain the details of the proposed change, the reason for the change, and the anticipated impact of the change.

Step 2: Review
The completed Raw Material Change Request form is then forwarded to the Change Control Committee (CCC) for review. The CCC will review the request and assess the potential impact of the change on the product quality and regulatory compliance. The review will include an assessment of alternative materials, suppliers, and impact on the manufacturing process.

Step 3: Approval
Upon approval of the change, the CCC will document the approval in the Raw Material Change Control form. The form will be signed by the change control committee members and forwarded to the concerned department personnel.

Step 4: Implementation
The implementation of the approved change will be initiated by the concerned department personnel. A plan should be developed for the implementation of the change, which should include the necessary testing and validation processes. The raw material supplier should also be informed of the change and the associated requirements for documentation, testing, and quality control.

Step 5: Verification
Upon implementation of the change, a verification process will be carried out to ensure that the change has been implemented as planned and expected. The results of the verification will be documented and reviewed by the CCC.

4. Documentation
All the steps involved in the Raw Material Change Control procedure should be documented. The following documents are to be maintained as a part of this procedure:

– Raw Material Change Request form
– Raw Material Change Control form
– Change Control Committee meeting minutes
– Verification report

5. Training
All the personnel involved in the Raw Material Change Control procedure should be adequately trained. The training should include an understanding of the importance of the procedure, the methods involved, and the documentation requirements.

6. Review
The Raw Material Change Control Procedure should be reviewed periodically by the Change Control Committee to ensure its continued suitability, effectiveness, and compliance with the applicable regulatory requirements.

7. Conclusion
The Raw Material Change Control Procedure ensures that any changes in raw materials used in the manufacturing process are managed in a structured and controlled manner. This approach helps to eliminate the risk of product quality issues and helps to maintain regulatory compliance.

1. Purpose:

The purpose of this SOP is to outline the procedure for returning raw materials that are deemed unusable or do not meet the required specifications.

2. Scope:

This SOP applies to all employees who handle or are involved in the return of raw materials.

3. Responsibility:

The Quality Control department shall be responsible for initiating the raw material return process and ensuring that the procedure is followed.

4. Procedure:

4.1 Raw materials that do not meet the required specifications or are damaged during transportation should be identified and isolated immediately.

4.2 The Quality Control department shall be informed of the identified raw materials for further investigation.

4.3 The Quality Control department shall conduct an inspection of the identified raw materials to determine the root cause of the issue.

4.4 If the raw material is deemed unusable or unsatisfactory for use in the manufacturing process, the Quality Control department shall initiate a raw material return request.

4.5 Upon approval of the raw material return request, the inventory department shall be notified of the return and asked to provide a return authorization number.

4.6 The raw materials shall be securely packaged and labeled with all the necessary information, including the return authorization number, batch number, and any other relevant information.

4.7 The raw materials shall be transferred to the designated return area under the supervision of the Quality Control department.

4.8 The Quality Control department shall ensure that the returned raw materials are properly inspected and approved before it is sent back to the supplier.

4.9 The raw materials return record shall be maintained, which includes information such as the supplier name, batch number, date of receipt, date of return, reason for return, and any relevant investigation reports.

4.10 The supplier shall be informed of the return, and the necessary documentation shall be shared with them.

5. References:

The procedure outlined in this SOP adheres to the requirements specified in the cGMP guidelines, company SOPs, and regulatory requirements.

6. Revision History:

This SOP shall be reviewed annually, and revisions made as necessary to ensure that the process remains effective and current with the company’s needs and regulatory requirements. Any revision made to this SOP shall be communicated to all relevant personnel.

2.0 Scope: This procedure applies to all raw materials used in the production of products at [Company Name].

3.0 Responsibility: The Quality Assurance (QA) department is responsible for the implementation and maintenance of the Raw Material Risk Assessment Procedure.

4.0 Procedure:

1. Raw Material Evaluation: The QA team shall evaluate the raw material used in the production of products based on the following parameters:

a. Regulatory compliance – The raw material must be in compliance with local and international regulations and standards.

b. Source of the raw material – The source of the raw material must be from reputed suppliers with a good track record.

c. Physical and chemical properties- The physical and chemical properties of the raw material must be analyzed to ensure that it is appropriate for the intended use.

d. Safety data sheets – The supplier must provide a safety data sheet for each raw material used.

2. Identify potential risks: Based on the evaluation, the QA team shall identify potential risks associated with the raw material used. Risks may include contamination, adulteration, or mislabeling.

3. Conduct a Risk Analysis: The identified risks shall be analyzed for the likelihood of occurrence and severity of consequences. This helps determine the risk level.

4. Determine risk level: The QA team shall determine the risk level for each potential risk, and categorize them into high, medium, or low risk based on the probability of occurrence and severity of consequences.

5. Develop and implement risk mitigation strategies: The QA team shall develop and implement risk mitigation strategies for each identified risk. Strategies may include testing the raw material for contaminants or verifying the supplier’s certification.

6. Review and update: The Raw Material Risk Assessment Procedure must be reviewed periodically to ensure its effectiveness and update it if necessary.

Conclusion: By adhering to this Standard Operating Procedure, we will ensure that raw materials used in the production of products are of high quality, safe, and compliant with regulatory standards.

2.0 Scope:

This SOP applies to all employees, contractors, and visitors who handle and manage raw materials at the company site.

3.0 Responsibilities:
1. The Quality Control unit is responsible for ensuring that the raw material handling record is maintained as per the SOP.
2. Production and warehouse personnel are responsible for handling and storing raw materials in accordance with the company’s procedures and requirements.

4.0 Procedure:
1. On receipt of raw materials, the warehouse personnel shall check the delivered quantity against the purchase order and other relevant documents to ensure, that the right product is received in the correct quantity.
2. All receipts must be documented in the inventory management system with the following details:
a. Date of the receipt
b. Quantity received
c. Supplier name
d. Batch or lot number
e. Expiry or re-test date, if applicable
3. The Quality Control unit shall perform a visual inspection of the received raw materials against the approved specifications and release the material to the production area.
4. The production personnel shall document the dispensing of the raw materials in the Dispensing Form, which includes the following details:
a. Date of dispensing
b. Quantity dispensed
c. Product name and code
d. Batch or lot number of the raw material
e. Employee details who dispensed the raw materials
f. Approval signature of the production supervisor
5. The Dispensing Form along with the raw material is taken to the production area for processing.
6. After the production process, the finished goods are kept in the warehouse and labeled with appropriate details such as batch or lot number, product name, and expiry or re-test date (if applicable).
7. The Quality Control personnel shall inspect the finished product for compliance with specifications before release.
8. The Quality Control unit shall document the acceptance and release of finished goods in the Finished Product Handling Record, which includes the following details:
a. Name and code of the finished product
b. Batch or lot number of the finished product
c. Quantity produced
d. Approval signature of the Quality Control personnel
9. The Finished Product Handling Record shall be reviewed, approved, and stored by the Quality Control unit.

5.0 Maintenance of Records:
All records related to raw material handling, dispensing, production, and finished product handling shall be maintained by the Quality Control unit for a minimum of 2 years after the expiry date of the finished product.

6.0 Training:
All employees, contractors, and visitors involved in handling raw materials shall be trained on this SOP and its implementation.

7.0 Revision History:
This SOP shall be reviewed and updated as necessary to reflect changes in regulatory requirements, company procedures, or best practices. Any revision to this SOP shall be approved and communicated to all relevant stakeholders.

2. Scope: This SOP shall be applicable to all employees involved in the receipt and storage of raw materials in our company.

3. Responsibilities:

3.1. Warehouse In-charge: The warehouse in-charge shall receive the raw materials and maintain the record of the receipt of raw materials.

3.2. Production In-charge: The production in-charge shall verify the quality of the raw materials received and approve the acceptance of the materials for further processing.

3.3. Quality Control Officer: The Quality Control Officer shall verify the quality of the raw materials and approve the acceptance of the materials for further processing.

4. Procedure:

4.1. Receipt of raw materials: The warehouse in-charge shall receive the raw materials and verify the packing list, purchase order, and quantity of the materials received.

4.2. Record keeping: The warehouse in-charge shall maintain a record of the receipt of raw materials including the name of the supplier, purchase order number, date of receipt, quantity received, batch number, and expiry date.

4.3. Quality verification: The production in-charge and the quality control officer shall verify the quality of the raw materials received and compare it with the standards set for the materials.

4.4. Approval for processing: The production in-charge and the quality control officer shall approve the acceptance of the raw materials for further processing based on the quality verification.

4.5. Storage: The warehouse in-charge shall store the raw materials in a designated and labeled area that is clean, dry, and secure.

4.6. Stock reconciliation: The warehouse in-charge shall periodically reconcile the stock of raw materials with the record maintained to ensure that there are no discrepancies.

4.7. Disposal of raw materials: The warehouse in-charge shall dispose of any raw materials that are damaged, expired, or of inferior quality.

5. Documentation: All records related to the receipt and storage of raw materials shall be maintained by the warehouse in-charge. The records shall include the packing list, purchase order, receipt record, quality verification record, and stock reconciliation record.

6. References:
ISO 9001:2015 Quality Management System – Requirements
Good Manufacturing Practices (GMP) guidelines

7. Record Retention: The record of raw materials received shall be maintained for a minimum of 3 years or as per company policy.

8. Revision History: Any changes made in this SOP shall be documented as the revision history and shall follow the SOP on “Document and Record Control.”

2. Scope:
This SOP applies to all raw materials used in the manufacturing process, including but not limited to raw materials received from suppliers, in-process materials, and finished products.

3. Responsibilities:
The Quality Assurance Department is responsible for implementing this procedure and ensuring compliance by all personnel involved in the handling and use of raw materials.

4. Procedure:
4.1 Raw Material Identification:
All incoming raw materials must be identified with a unique code or batch number that provides traceability throughout the manufacturing process. The identification system must be approved by the Quality Assurance Department.

4.2 Raw Material Storage:
All raw materials must be stored in designated areas that are clearly labeled with the name of the material, the date of receipt, and the batch number. Raw materials must be segregated from each other to prevent cross-contamination.

4.3 Raw Material Usage:
Once a raw material has been issued for use, the Production Department must record the material’s batch number and quantity used in the batch record.

4.4 Recording of Usage:
Every production batch must have clear documentation indicating which raw materials were used in the process and their corresponding batch numbers. This documentation must be kept by the Production Department and made available to the Quality Assurance Department upon request.

4.5 Traceability:
If a quality issue arises during the manufacturing process, the Quality Assurance Department must be able to trace the affected batch number of the raw material back to the supplier and the specific lot number received.

4.6 Quarantine Procedures:
Any raw materials that have been identified as non-conforming must be placed in quarantine and isolated from all other materials until their disposition has been determined by the Quality Assurance Department.

4.7 Disposition of Non-conforming Raw Materials:
Non-conforming raw materials must be evaluated by the Quality Assurance Department to determine their disposition. The disposition may be to return the materials to the supplier or to discard them following appropriate procedures.

5. Records:
All records generated as part of this Raw Material Traceability Procedure must be maintained according to the company’s document control procedures.

6. Training:
All personnel involved in the handling, storage, and use of raw materials must be trained on this procedure and its importance in maintaining product quality.

7. Conclusion:
Following this SOP ensures traceability of all raw materials used in the manufacturing process. This procedure provides an effective tool to prevent non-compliance, minimize production losses, and protect consumer safety. The Quality Assurance Department is responsible for ensuring compliance with this SOP.

2.0 Scope
This SOP applies to all employees involved in the receiving and verification of raw materials at the company.

3.0 Responsibility
Quality Control Department is responsible for verification of raw materials regarding their specification, identification, and suitability for use.

4.0 Procedure

1. Receiving
a. Raw materials must only be received from approved vendors.
b. Upon receipt, the delivery documents must be checked for accuracy and completeness.
c. Raw materials must be kept in a designated area until they are verified.
d. The received raw materials must be registered in a logbook for tracking and reference.

2. Initial Verification
a. The labels and documentation of the raw materials should be checked to confirm that it matches the purchase order.
b. The containers holding raw materials should be checked to confirm the material’s consistency, texture, and color.
c. Any visible damages or defects, such as dents, tears, or cracks on the packaging, should be noted.
d. If there is any deviation from the specifications or if the material appears damaged, the raw material should be quarantined, and the supplier notified.

3. Sampling
a. A representative sample must be taken from each lot/batch of raw materials.
b. Samples should be taken following the written procedure and using appropriate sampling tools.
c. The samples should be properly labeled and stored in a refrigerated or controlled temperature area.

4. Analysis
a. The samples must be analyzed according to the written protocol.
b. The analysis can be conducted in-house or by a contracted laboratory. If the contracted lab is used, the lab should be accredited, and the certificate of analysis should be available for review.
c. The lab analysis or microbiological results of raw material sample should be recorded.

5. Conclusion
a. After analysis, the samples are either accepted or rejected.
b. If the raw material is accepted, it must be properly labeled and stored in the appropriate location.
c. If the raw material is rejected, it must be returned to the vendor or destroyed according to the written procedure.
d. Raw material used for production must also be attached with QA Release label stating the raw material has been verified by the quality control.

5.0 Documentation
All procedures and results must be documented as per the company’s policy.

6.0 Training
All employees carrying out the procedure of Raw Material Verification must be trained in the correct handling, analysis, and documentation procedures required in this SOP.

7.0 Revision
This SOP shall be reviewed every five (5) years or earlier if necessary.

8.0 References
The SOP is based on ISO 9001:2015 requirements for raw material controls, quality standards, guidelines for raw material, certification of analysis, raw material receiving inspection checklist, and batch records.

1.0 Purpose:
The purpose of this standard operating procedure is to outline the procedure for the release of raw materials at the manufacturing facility. This SOP is intended to ensure the quality and safety of the raw materials used in the production process, as well as to comply with regulatory requirements.

2.0 Scope:
This SOP applies to all raw materials used in the manufacturing process at the facility. In addition, it applies to all personnel involved in the raw material release process.

3.0 Responsibilities:
1. Quality Assurance: Quality Assurance shall be responsible for ensuring that the raw materials meet the required specifications before they are released for use in production.
2. Warehouse Personnel: Warehouse personnel shall be responsible for managing the inventory of raw materials and ensuring that they are properly labeled, stored, and controlled.
3. Production Personnel: Production personnel shall be responsible for ensuring that the raw materials are properly identified, weighed, and verified before they are used in the manufacturing process.
4. Document Control: Document Control shall be responsible for maintaining records related to raw material release, such as purchase orders, certificates of analysis, and other relevant documentation.

4.0 Procedure:

1. Receipt of Raw Materials:
1.1 Upon receipt of the raw materials, the Warehouse personnel shall verify the identity, quantity, and condition of the materials against the accompanying purchase order.
1.2 Any discrepancies shall be reported to the Quality Assurance department for investigation.
1.3 The raw materials shall be stored in a designated location in the warehouse.

2. Review of Documentation:
2.1 The Quality Assurance department shall review the accompanying documentation for each raw material, including the certificate of analysis, to verify that the materials meet the required specifications.
2.2 If the raw materials do not meet the required specifications, they shall be rejected and returned to the supplier.

3. Sampling and Testing:
3.1 The Quality Assurance department shall take a representative sample from each lot of raw materials, as per the sampling plan.
3.2 The sample shall be tested for compliance with the required specifications, as per the established testing plan.
3.3 If the raw materials pass the required testing, the Quality Assurance department shall approve the release of the materials for use in production.

4. Release of Raw Materials:
4.1 Once the raw materials have been approved for release, a release note shall be issued by the Quality Assurance department.
4.2 The release note shall be attached to the raw materials or entered into the ERP system.
4.3 Warehouse personnel shall release the approved raw materials to the production department, along with the corresponding release note.

5. Disposition of Non-Conforming Materials:
5.1 If raw materials are found to be non-conforming during any stage of the release process, they shall be identified as such and quarantined.
5.2 The Quality Assurance department shall investigate the non-conformance and determine the appropriate disposition of the materials, which may include disposal or return to the supplier.

6.0 Record Keeping:
6.1 All documentation related to the raw material release process, including purchase orders, certificates of analysis, testing results, release notes, and any other relevant documents, shall be filed and stored for a minimum of seven years.
6.2 The Document Control department shall be responsible for maintaining these records and ensuring their availability for inspection by regulatory authorities.

7.0 Training:
All personnel involved in the raw material release process shall receive appropriate training on this SOP and their respective roles and responsibilities.

8.0 Revision History:
This SOP shall be reviewed and updated as necessary to ensure its continued suitability and effectiveness. Any changes to the SOP shall be documented and communicated to all relevant personnel.

The purpose of this Standard Operating Procedure (SOP) is to establish the procedure for inspecting raw materials before accepting them for use in the manufacturing process. This SOP aims to ensure that all incoming raw materials meet the required quality standards and specifications.

2.0 Scope:

This SOP is applicable to all personnel involved in the receipt, inspection, and acceptance of raw materials in the manufacturing process.

3.0 Responsibilities:

The following personnel are responsible for implementing and following the Raw Material Inspection Procedure:

– Procurement Manager – Responsible for ensuring that raw materials are procured from approved suppliers and that all quality requirements are met.

– Quality Control Manager – Responsible for inspecting all incoming raw material and approving or rejecting them based on the quality standards.

– Warehouse Supervisor – Responsible for receiving the raw materials and coordinating with the Quality Control Manager for inspection.

4.0 Procedure:

1. Upon receipt of raw materials, the Warehouse Supervisor will verify if the materials match the purchase order and delivery note. Any discrepancies shall be reported immediately to the Procurement Manager.

2. The Quality Control Manager will undertake a visual inspection of the incoming raw materials to ensure that they are free from damage, contamination, or any other visible defects.

3. The Quality Control Manager will obtain a sample for testing as per the applicable quality control plan. The location and size of the sample and the testing method will be as per the approved testing procedure.

4. The Quality Control Manager will conduct the necessary tests based on specifications and standards, such as physical, chemical, and microbiological tests.

5. Based on the results of inspection and testing, the Quality Control Manager will approve or reject the raw material. Approved raw materials will be issued to the production department for use, while rejected materials will be stored separately and returned to the supplier, if necessary.

6. Inspection records will be maintained in the warehouse for a specified period as per the organization’s policies.

5.0 Documentation:

All raw material inspection information shall be documented on the appropriate forms and logs, which should include:

– Date of receipt of raw materials
– Details of the supplier, Purchase order, and delivery note
– Results of visual inspection and quality tests done
– Signature of the Quality Control Manager approving or rejecting the raw materials

6.0 Conclusion:

This SOP will ensure all incoming raw materials are inspected and approved as per organizational quality standards. This procedure will also ensure that only quality raw materials are used in the manufacturing process, leading to high-quality finished products.

The purpose of this SOP is to establish procedures for the destruction of raw materials that are no longer usable or have expired, to ensure they are disposed of in a safe and environmentally-friendly manner.

Scope:

This SOP applies to all raw materials that are in possession of the facility and need to be destroyed.

Responsibilities:

The Quality Control (QC) department is responsible for the identification, segregation, and documentation of the raw materials that require destruction. The Production department and/or a external disposal contractor is responsible for the actual destruction of the materials in accordance with this SOP.

Procedure:

1. QC will identify any raw material that has expired or is no longer usable and segregate it from other materials. Expired raw materials will have a red tag placed on them, while materials that are no longer usable will be marked with a black tag.

2. The QC department will fill out a Raw Material Destruction Form. The form will include the raw material name, batch number, quantity, reason for destruction, and date.

3. The Production department will be notified about the raw materials that need to be destroyed.

4. The Production department will weigh the materials and record the weight on the Raw Material Destruction Form.

5. The Production department will transfer the materials to a designated area for destruction.

6. The external disposal contractor will destroy the materials using appropriate methods that adhere to all local, state, and federal regulations, and dispose of them in an environmental-friendly manner.

7. The Production department will record the destruction of the materials on the Raw Material Destruction Form, including the date, time, and method of destruction.

8. The Quality Assurance department will review and approve the Raw Material Destruction Form.

9. The Raw Material Destruction Form will be kept in the company records.

Conclusion:

This SOP ensures that raw materials are destroyed in a safe and environmentally-friendly manner, and that all requirements of local, state, and federal regulations are met.