PRODUCT LIST IN PHARMACEUTICAL

• OBJECTIVE:

To lay down a procedure for Product List.

• SCOPE:

This SOP is applicable for product list at {Company Name} {Company Location}.

• RESPONSIBILITY:

• QA officer/executive- Follow the instruction as per procedure.

• ACCOUNTABILITY:

QA Head shall be accountable for compliance of this SOP.

• PROCEDURE:

• Product list shall be prepared by QA Executive/Designee, reviewed by QA Sr. Executive/designee and approved by QA head/Designee.

• Product list number shall be assigned as:

AAA/BB-XX-YYY

Where:

AAA	:	Indicates to {Company Name}
/	:	Indicates to Separator
BB	:	Indicates to Quality Assurance.
–	:	Indicates to Hyphen
XX	:	Indicates to Finished products.
YYY	:	Indicates to serial number for product list

• The Product List shall contain Sr. No, Generic Name, Composition, Pharmacopoeia Reference, and Claim. (As per Annexure-I).

• The Annexure-I shall be Applicable for the preparation of product list for Tablet, Capsule, Liquid.
  • QA Executive/Designee shall prepare the product list for the product.

• QA Sr. Executive/Designee shall review the product list.

• QA head/Designee shall review and approve the product list.

• The product list shall be updated at least once in a year or whenever required.

• Discontinued products shall be removed from the product list at least once in a year or whenever required.

• REFERENCES:

Not Applicable.

• ANNEXURES:

ANNEXURE No.	TITLE OF ANNEXURE
Annexure-I	Product List

• 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
No.	:	Number
Ref.	:	Reference

• REVISION HISTORY:                 

                                                                      CHANGE HISTORY LOG

Revision No.	Details of Changes	Reason for Change	Effective Date
00	New SOP	Not Applicable	To be written manual

              ANNEXURE-I

PRODUCT LIST
Product List No.:		Effective Date :
Revision No.:		Revision Date :

Sr. No	Generic Name	Composition	Therapeutic class	Dosage Form

Frequently Asked Question?

1. What is the importance of maintaining an updated pharmaceutical product list?
   • Answer: An updated product list is crucial for providing accurate information on available medications, ensuring patient safety, aiding healthcare professionals in making informed decisions, and complying with regulatory requirements.
2. How do pharmaceutical companies categorize products in their lists?
   • Answer: Products are typically categorized based on therapeutic class, dosage form, active ingredients, and brand names for clarity and ease of reference.
3. What role does a product list play in regulatory compliance?
   • Answer: A product list helps pharmaceutical companies adhere to regulatory guidelines by providing a transparent overview of their offerings, aiding authorities in monitoring and ensuring compliance.
4. How does a comprehensive product list benefit healthcare professionals?
   • Answer: Healthcare professionals rely on product lists to access detailed information about medications, including indications, contraindications, and dosage forms, enabling them to make informed prescribing decisions.
5. What challenges do pharmaceutical companies face in managing and updating their product lists?
   • Answer: Challenges include keeping up with evolving regulations, managing diverse product portfolios, and ensuring accurate and timely updates to reflect new product launches or discontinuations.
6. How can a well-organized product list improve inventory management for pharmaceutical companies?
   • Answer: A well-organized product list facilitates efficient inventory management by providing clear insights into stock levels, expiration dates, and reorder points, helping companies optimize their supply chain.
7. In what ways does a product list contribute to patient safety?
   • Answer: By providing accurate information on drug interactions, contraindications, and proper usage, a product list supports healthcare professionals in prescribing medications safely, minimizing risks to patients.
8. How do pharmaceutical companies handle the marketing of new products in their lists?
   • Answer: Companies typically engage in targeted promotional activities, collaborate with healthcare professionals, and update their product lists to include comprehensive information on new launches.
9. Why is standardization important in pharmaceutical product lists?
   • Answer: Standardization ensures consistency in information presentation, making it easier for healthcare professionals, distributors, and regulatory bodies to interpret and utilize the data effectively.
10. How does technology influence the management of pharmaceutical product lists?
    • Answer: Technology plays a key role in automating updates, maintaining real-time information, and enhancing accessibility through digital platforms, improving overall efficiency and accuracy in managing product lists.

11. What information is included on the list?

Answer: Product listings typically provide details like:

• Brand and generic names
• Active ingredients and their dosages
• Indications (approved uses)
• Contraindications (conditions preventing use)
• Side effects and warnings
• Dosage and administration instructions
• Form (tablet, capsule, injection, etc.)