Introduction for Raw Material and Finished Product Analysis
Raw Material and Finished Product Analysis-Quality Control plays a central role in ensuring that only materials and pharmaceutical products meeting their approved requirements are used or released. In an Oral Solid Dosage (OSD) manufacturing facility, this includes active pharmaceutical ingredients (APIs), excipients, packaging materials, in-process or semi-finished materials, and finished tablets or capsules.
This procedure describes a practical GMP-based approach for the analysis and approval or rejection of raw materials, packing materials, semi-finished products and finished products in an OSD pharmaceutical facility.
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What Is Analysis and Approval/Rejection?
Analysis and approval/rejection is the controlled process by which Quality Control evaluates a material or pharmaceutical product against its approved specification before it is permitted for use or release.
The process normally includes:
Receipt → Quarantine → Sampling → Testing → Result Review → OOS/OOT Investigation, if applicable → QC Assessment → QA Review/Release → Approved or Rejected Status
For raw materials and packaging materials, the decision determines whether the material can be issued for manufacturing or packaging.
For finished products, analytical results are considered together with the relevant manufacturing, packaging, deviation and other quality records before final batch release according to the site’s quality system.
Why Is This Procedure Required?
The procedure is required to make sure that:
- Only materials meeting approved specifications are used in manufacturing.
- Packaging materials are suitable for their intended use.
- Finished products meet approved quality requirements before release.
- Sampling and testing are performed using approved procedures.
- Laboratory results are properly recorded and independently reviewed.
- OOS and OOT results are investigated appropriately.
- Material and product status remains clearly identified.
- Unauthorized use or release of quarantined material is prevented.
- Complete traceability is maintained from receipt through final disposition.
- Quality Control and Quality Assurance responsibilities remain clearly defined.
A strong approval/rejection system is therefore an important part of the pharmaceutical quality system.
Regulatory/GMP Expectations for Raw Material and Finished Product Analysis
GMP requirements place significant responsibility on the Quality Control/Quality Unit for sampling, testing, review and release decisions.
Under 21 CFR 211.84, each lot of components, drug product containers and closures must be withheld from use until appropriately sampled, tested or examined and released by the quality control unit. The regulation also requires representative sampling and appropriate identity testing.
EU GMP Chapter 6 similarly emphasizes approved sampling and testing procedures, validated methods, documented results, investigation of deviations/OOS results and formal assessment of testing against specifications.
Responsibilities
| Designation | Responsibilities |
| Q.C officer/Executive /Designee. | Receive samples along with the approved sampling/request documentation.Verify sample identification and quantity.Perform testing according to the current approved STP, specification and applicable pharmacopoeial method.Record observations, calculations and results at the time of testing.Review chromatograms, spectra and other supporting data.Confirm that results comply with approved specifications.Review the COA for correctness. |
| Department Head/ authorized designate by the Head. | Ensure analysts are trained and qualified.Ensure approved specifications and STPs are available.Review and approve laboratory records as defined in the site’s procedure. |
| IPQA Person | Collect or supervise sampling where required by the approved sampling procedure.Provide representative samples to QC.Ensure appropriate identification of samples.Provide samples of bulk, semi-finished, finished, validation, hold-time and stability batches as applicable. |
| Quality Assurance Department | Review relevant quality records.Review deviations, OOS/OOT investigations and CAPA where applicable.Ensure material/product disposition follows the approved quality system.Approve or authorize final release/rejection according to the site’s responsibilities.Ensure rejected materials/products are appropriately controlled. |
Procedure for Raw Material and Finished Product Analysis
Analysis of Raw Materials
Receipt and Quarantine
After receipt of a raw material, the material shall be identified and kept under quarantine until the required sampling, testing and quality review are completed.
The material should have adequate identification showing information such as:
- Material name
- Material code
- Supplier/manufacturer
- Batch or lot number
- Quantity received
- Receipt date
- Quarantine status
Sampling Request
The Stores/Warehouse department shall provide the required receipt documentation, such as the GRN, to QC according to the approved procedure.
QC shall verify the material identity and sampling requirements before sampling.
Sampling
Sampling shall be performed using the approved sampling SOP.
The sample shall be representative of the material lot and collected in a manner that prevents contamination, mix-up and deterioration.
The sample quantity shall be sufficient for:
- Required testing
- Repeat testing where scientifically justified
- Reference/reserve sample requirements, where applicable
Sample Receipt in QC
After sampling, the QC department shall record the sample in the applicable inward/sample register or electronic system.
The sample label should contain adequate identification, including:
- Material name
- Batch/lot number
- Sample number
- Date of sampling
- Sampled quantity, where applicable
- Storage conditions, where required
Testing
The analyst shall perform testing according to the current approved specification and STP.
Depending on the material, testing may include:
- Description/appearance
- Identification
- Assay
- Related substances/impurities
- Water content or loss on drying
- Residue on ignition
- pH
- Particle size
- Microbiological quality
- Specific physical or chemical characteristics
The applicable pharmacopoeial monograph shall be followed where specified by the approved specification.
Recording of Results
All observations, raw data and calculations shall be recorded contemporaneously in the approved worksheet, laboratory record or validated electronic system.
Instrument-generated data shall be retained according to the applicable data-integrity and record-retention requirements.
Analysis of Packing Materials
Packing materials can include:
- Printed cartons
- Labels
- Foils
- Bottles
- Leaflets
- Shippers
- Alu-Alu
- PVC/PVDC films
- Other primary or secondary packaging components
Receipt and Quarantine
Packing materials shall remain under appropriate quarantine/control status until sampling, examination/testing and approval are completed.
Sampling
Sampling shall be performed according to an approved sampling plan.
Depending on the material, sampling and examination may include:
- Visual inspection
- Dimensions
- Thickness
- GSM
- Colour
- Printing details
- Text verification
- Barcode verification
- Artwork/version verification
- Seal characteristics
- Physical integrity
- Material identification
- Functional testing where applicable
Testing and Examination
The analyst shall compare the received material against the approved specification, artwork and applicable test procedure.
Particular attention should be given to printed packaging materials because incorrect text, batch coding areas, product information or artwork versions can create serious mix-up risks.
Review and Disposition
The completed records shall be reviewed by the QC Reviewer.
If all requirements are met, the material may be recommended for approval.
If the material fails to meet an approved requirement, it shall remain under controlled status until the investigation and final disposition are completed.
Analysis of Finished Products
Finished product analysis is one of the most important QC activities before batch release.
Sample Receipt
After completion of manufacturing and the required sampling activity, the finished product sample shall be submitted to QC with the approved sample request/documentation.
The QC department shall record the sample in the finished product inward register or validated electronic system.
Sample Verification
The analyst shall verify:
- Product name
- Batch number
- Manufacturing date
- Sample number
- Sample quantity
- Sampling date
- Storage condition, where applicable
- Sample container/pack identification
Any discrepancy should be reported before testing begins.
Testing
The finished product shall be tested according to the approved finished product specification and STP.
For OSD products, testing may include, as applicable:
- Description
- Identification
- Average weight
- Weight variation
- Hardness
- Friability
- Disintegration
- Dissolution
- Assay
- Content uniformity
- Related substances
- Water content
- Microbial limits
- Other product-specific tests
Not every test applies to every product. The approved specification shall always be the controlling document.
Analytical Data Recording
The analyst shall record results directly into the approved worksheet or validated computerized system.
Examples of supporting records include:
- HPLC chromatograms
- GC chromatograms
- UV spectra
- IR spectra
- Dissolution printouts
- Balance records
- Instrument calculations
- System suitability results
- Microbiological results
QC Review
The QC Reviewer shall review the complete analytical package.
The review should confirm that:
- The correct sample was tested.
- The correct method was used.
- Required system suitability criteria were met.
- Calculations are correct.
- All required tests were completed.
- Results comply with specifications.
- Raw data is complete and attributable.
- No unexplained discrepancies are present.
COA Preparation
After completion and review of testing, the Certificate of Analysis (COA) shall be prepared using the approved format.
The COA shall contain accurate information corresponding to the approved batch records and analytical results.
It shall be reviewed and approved according to the site’s authorization matrix.
Final Batch Release
QC analytical compliance is an important part of batch release, but final release should also consider the applicable manufacturing, packaging, deviation, investigation and other quality records.
The authorized QA/Quality Unit shall make the final release decision according to the site’s approved procedure and applicable regulatory requirements.
EU GMP, for example, specifically requires formal assessment of testing against specification together with review of relevant production documentation and deviations.
Handling OOS and OOT Results during Raw Material and Finished Product Analysis
If any analytical result falls outside the approved specification, the analyst shall immediately inform the QC supervisor.
The batch/material shall not be declared acceptable simply because another test result subsequently passes.
The OOS procedure shall be initiated according to the approved site procedure.
The investigation should consider, as applicable:
- Analytical procedure
- Calculations
- Sample preparation
- Reagents and standards
- Instrument performance
- System suitability
- Glassware
- Analyst technique
- Laboratory environment
- Sample integrity
- Manufacturing/process records
- Previous and related batch results
The FDA OOS guidance recommends a scientifically sound investigation of OOS results and distinguishes laboratory investigation from the broader manufacturing investigation.
Where no assignable laboratory cause is established, the investigation should not simply use repeated testing to obtain a passing result.
Rejection Procedure – Raw Material and Finished Product Analysis
A material or product should be rejected when it does not meet its approved requirements and the investigation/disposition process determines that it is unsuitable for use or release.
Examples include:
- Failed identity test
- Assay outside specification
- Failed dissolution
- Failed content uniformity
- Incorrect packaging material
- Wrong artwork/version
- Damaged packaging component
- Microbial failure
- Failure of an approved physical specification
- Confirmed OOS result
- Other critical quality failure
Rejected materials shall be physically or electronically controlled to prevent unintended use.
Where applicable, the material shall be transferred to a designated rejection area with clear REJECTED status.
The final disposition shall be documented.
Flow Chart for Raw Material and Finished Product Analysis
A practical workflow can be organized as follows:
Material/Product Received
↓
Quarantine Status Applied
↓
Sampling by Authorized Personnel
↓
Sample Submitted to QC
↓
Sample Registration
↓
Testing According to Approved STP/Specification
↓
Raw Data Recording
↓
Independent QC Review
↓
Complies With Specification?
YES → QC Recommendation/Approval → QA/Authorized Release → Approved Status
NO → OOS/OOT/Deviation Investigation → Final Disposition
↓
Rejected, Reprocessed/Retested Where Scientifically and Procedurally Justified, or Other Approved Disposition
Common Mistakes during Raw Material and Finished Product Analysis
Testing Against an Obsolete Specification
Always verify that the current approved specification and STP are being used.
Releasing Material Before Testing Is Complete
Quarantined material must not be used before the required testing and authorized release are completed.
Ignoring Packaging Material Defects
A packaging component can directly affect product identity, protection and correct presentation. It should therefore be evaluated against its approved specification.
Incomplete Batch Review
Finished product release should not rely only on the COA. Relevant manufacturing, packaging, deviation and investigation records should also be reviewed according to the site’s batch-release procedure.
Poor Status Identification
Quarantine, Approved and Rejected materials must be clearly distinguishable to prevent accidental use.
Required Documents
The following records may be generated or maintained as part of this procedure:
- Material inward register
- Finished product inward register
- GRN
- Sampling request
- Sampling record
- Sample labels
- Raw data sheets
- Analytical worksheets
- Approved specifications
- Standard Testing Procedures
- Pharmacopoeial monographs
- Instrument printouts
- HPLC/GC chromatograms
- UV/IR spectra
- System suitability records
- OOS investigation reports
- OOT investigation reports
- Deviation reports
- CAPA records
- Certificate of Analysis
- Material approval/rejection records
- Finished product release records
- Rejection/disposal records
- Reference/retention sample records, where applicable
FAQs for Raw Material and Finished Product Analysis
Can raw materials be used before QC approval?
No. Materials requiring QC testing and release should remain under the appropriate controlled status until the required testing and authorized release have been completed.
Is supplier COA enough for raw material approval?
No, In-house testing should be required and further on trend basis you can apply reduce testing approach.
What happens if a finished product fails one test?
The product should not be released based on the failure being ignored. The approved OOS/investigation procedure should be followed and the final disposition should be based on investigation outcomes.
Who makes the final decision to release a finished batch?
This depends on the site’s approved quality system and applicable regulatory requirements. QC provides analytical assessment, while the authorized Quality/QA function performs the final batch disposition where that responsibility is assigned.
What is the difference between approval and release?
Approval generally refers to determining that a material or product meets specified requirements. Release is the formal authorization allowing a material to be used or a finished product to be distributed according to the site’s quality system.
Should rejected materials be physically segregated?
Yes. Rejected materials should have clear status identification and be controlled to prevent unintended use.
What records should be reviewed before finished product release?
The review should include applicable analytical results and relevant manufacturing, packaging, deviation, investigation and other quality records required by the site’s batch-release procedure.
References
- 21 CFR 211.84 – Testing and approval or rejection of components, drug product containers, and closures.
- EU GMP Guide, Chapter 6 – Quality Control.
Conclusion
A controlled procedure for the analysis and approval/rejection of raw materials, packing materials and finished products is essential for maintaining consistent product quality in an OSD pharmaceutical facility.
The process should begin with controlled receipt and representative sampling, followed by testing against approved specifications, complete documentation and independent review. Any OOS, OOT or other abnormal result should be investigated through the approved quality system rather than being bypassed through undocumented retesting.
Most importantly, a material or product should never be released simply because the laboratory result appears acceptable. The decision should be based on complete, traceable and scientifically supported quality information.
When QC testing, data review, investigation and QA/authorized disposition work together, the system provides a reliable barrier against unsuitable materials entering production and non-conforming products reaching patients.