- OBJECTIVE:
To lay down a procedure for allocation of manufacturing and expiry date to the pharmaceutical products.
- SCOPE:
This SOP is applicable for allocation of manufacturing and expiry date to the products manufactured at {Company Name} {Location}.
- RESPONSIBILITY:
- QA & production personnel- Follow the instruction as per procedure.
- ACCOUNTABILITY:
QA Head Shall be accountable for implementation of SOP.
- PROCEDURE:
- The manufacturing date is assigned month wise as well as date wise.
- If manufacturing and expiry is assigned month wise, then start date of raw materials (active and excipient’s) dispensing month will be consider as manufacturing month.
- If manufacturing and expiry is assigned date wise, then start date of raw materials (active and excipient’s) dispensing will be consider as manufacturing date.
- On receipt of requisition from production, QA officer shall issues the batch manufacturing record and batch packaging record for the particular product & batch.
- At the time of issuance of batch records, QA officer shall allocate the manufacturing and expiry date for that particular batch.
- Expiry date shall be assigned as per stability data.
- QA officer shall records the manufacturing and expiry date on the first page of the batch manufacturing and batch packing record and also in the issuance register.
- The manufacturing date shall be allocated in the form of MM/YYYY, (In case of month wise date allocation)
Where:
MM – Indicates the numeric month
YYYY – Indicates to year
For example: MM/YYYY = 01/2024. i.e. the product has manufacturing date 01/2024
- The expiry date shall be allocated in the form of MM/YYYY
Where:
DD – Indicates the numeric month
YYYY – Indicates to year
For example: MM/YYYY = 12/2025. i.e., the product has expiry date 12/2025.
- The manufacturing date shall be allocated in the form of DD/NN/XXXX, (In case of month wise date allocation)
Where:
DD- Indicate the start date of manufacturing
MM – Indicates the numeric month
YYYY – Indicates to year
For example: DD/NN/XXXX = 22/01/2024. i.e. the product has manufacturing date 22/01/2024
The expiry date shall be allocated in the form of DD/NN/XXXX
Where:
DD- Indicate the start date of manufacturing
MM – Indicates the numeric month
YYYY – Indicates to year
For example: DD/NN/XXXX = 21/01/2026. i.e., the product has expiry date 21/01/2026.
- The expiry date shall be allocated to the batch based on the shelf life assigned to the product in the respective master formula.
- If product is having 2 year shelf life then it will be assign in the following way:
Date for the start of raw material Dispensing: 22/01/2025
Month Wise Allocation:
Manufacturing Date: 01/2025
Expiry Date: 12/2026
Date Wise Allocation:
Manufacturing Date: 22/01/2025
Expiry Date: 21/01/2027
- Manufacturing and expiry date can be allocated in the different form as per party/customer requirement.
- REFERENCES:
Not applicable.
- ANNEXURES:
Not applicable.
ENCLOSURES: SOP Training Record.
- DISTRIBUTION:
- Controlled Copy No. 01 : Head Quality Assurance
- Controlled Copy No. 02 : Head Quality Control
- Controlled Copy No. 03 : Head Production
- Controlled Copy No. 04 : Head Warehouse
- Master Copy : Quality Assurance Department
- ABBREVIATIONS:
| QA | : | Quality assurance |
| SOP | : | Standard operating procedure |
| EXP | : | Expiry |
| MFG | : | Manufacturing |
- REVISION HISTORY:
CHANGE HISTORY LOG
| Revision No. | Details of Changes | Reason for Change | Effective Date |
| 00 | New SOP | Not Applicable | To Be Enter Manual |
Frequently Asked Questions ?
1. Who is responsible for determining the manufacturing and expiry dates of pharmaceuticals?
Answer: Ultimately, the manufacturer is responsible for determining both the manufacturing date (batch date) and expiry date of their products. This is done through a rigorous process involving:
- Stability testing: Studying how the product degrades over time under various storage conditions.
- Risk assessment: Evaluating potential factors affecting product stability, including ingredients, packaging, and manufacturing process.
- Regulatory requirements: Adhering to guidelines set by regulatory bodies like the FDA or EMA.
2. How are manufacturing dates typically assigned?
Answer: Manufacturing dates are usually assigned based on the completion of the final production and quality control steps for a specific batch. This date is typically printed on the product packaging and batch records.
3. What factors influence the expiry date of a pharmaceutical product?
Answer: Several factors influence a product’s expiry date, including:
- Ingredient stability: The inherent stability of the active pharmaceutical ingredients (APIs) and other components.
- Dosage form: Different forms (e.g., tablets, liquids) have varying stability profiles.
- Packaging: The type and quality of packaging can impact stability and protect the product from external factors.
- Manufacturing process: Variations in the manufacturing process can affect product stability.
- Storage conditions: Improper storage temperatures, humidity, or light exposure can shorten shelf life.
4. What happens if a pharmaceutical product nears its expiry date?
Answer: Products approaching expiry should be removed from distribution and disposed of properly. Using expired medications can be ineffective or even dangerous due to potential degradation of the active ingredients or formation of harmful byproducts.
5. Can the expiry date be extended?
Answer: In some cases, manufacturers can seek regulatory approval to extend the expiry date if they have additional stability data demonstrating the continued safety and efficacy of the product beyond the initial date. This is a complex process with strict requirements.
6. How does the allocation of manufacturing and expiry dates impact inventory management?
Answer: Accurate expiry dates are crucial for effective inventory management. Manufacturers and distributors need to plan production and distribution schedules to avoid expiring products and ensure timely availability of essential medications.
7. Are there any legal or regulatory requirements for expiry date labeling?
Answer: Yes, most regulatory bodies have specific labeling requirements for expiry dates on pharmaceutical products. These requirements typically include:
- Clearly visible and legible format (e.g., “EXP” or “Expiry”)
- Placement on the primary packaging and outer carton
- Use of a specific date format (e.g., MM/YY)
8. What are some best practices for managing expiry dates in the pharmaceutical industry?
Answer: Best practices include:
- Implementing robust stability testing programs.
- Maintaining accurate and complete batch records.
- Using effective inventory management systems to track expiry dates and prioritize distribution.
- Implementing first-in-first-out (FIFO) inventory management to avoid older products expiring before newer ones.
- Educating healthcare providers and consumers about the importance of expiry dates and proper disposal of expired medications.
9. How can technology help in managing pharmaceutical expiry dates?
Answer: Advances in technology offer several solutions, including:
- Real-time inventory tracking systems with expiry date alerts.
- Blockchain-based platforms for secure and transparent product tracking and expiry management.
- Artificial intelligence (AI) and machine learning (ML) algorithms for predicting product degradation and optimizing expiry date allocation.
10. What are the ethical considerations for allocating expiry dates to pharmaceuticals?
Answer: It’s crucial to consider ethical implications like:
- Ensuring access to essential medications for all, including low-resource settings.
- Minimizing waste and environmental impact associated with expired products.
- Promoting responsible use and disposal of medications to avoid potential harm.
