documentation Flashcards
It is an essential part of a good manufacturing practices. It defines a scheme of information so that risks of characteristic in misconception and/or error in oral communication will be minimized.
Documentation
It subsequently supports the quality, and its uniformity, of all goods and services, as those in charge for the specific operations have clear, definite instructions to follow including active drug substances, is legally mandatory.
Documentation
Coverage of Documentation
• Building and premises
• Personnel
• Equipment
• Materials
• Processing
• Finished goods
• Complaints
It is a specific document compiled, checked, authorized and approved by an experienced personnel as necessary and appropriate.
As with any other documentation, it shall also be open for review. If there are changes, it should be approved by designated staff responsible for production and quality control.
Master formula record
It is one of the function of quality control. This function is performed by alert individual who have understood the written instructions is provide in the SOP on how to inspect certain quality characteristics
Inspection
It is a step by step method on how to go about a specific job. In inspection, should include one of those of the basic types of information needed by an inspector
Standard Operating Procedure (SOP)
the inspector has to know what operation come before and after his inspection
when to inspect
He should know what to look for during inspection
what to inspect
what is acceptable and what is unacceptable for each
characteristics inspected
Inspection Standards
The procedures that will results in the most effective inspection and that will permit reliable interpretation of the results of inspection
Inspection Method
the inspector has to know the data recording and reporting procedures so that the information he provides can be truly reliable
How to report data
he has to know the appropriate actions to take with the materials he handles
Material Handling
the inspector has to know the rules and procedures which govern his conduct on the job
Administrative procedures
AO for Guidelines for Manufacturers and Traders
Administrative Order No. 2019-0007
To provide stakeholders engaged in the manufacturing processes for ENDS/ENNDS products a general overview of FDA’s regulation for manufacturers and traders
Administrative Order No. 2019-0007
To ensure that all concerned stakeholders understand the process for the application of a license to operate and the regulatory requirements during operations
Administrative Order No. 2019-0007
It means an establishment engaged in any and all operations involved in the production of health products including preparation, processing, compounding, formulating, filling, packing, repacking, altering, ornamenting, finishing and labeling with the end in view of its storage, sale or distribution.
Manufacturer
They shall be categorized a manufacturer.
Trader
It means any establishment which is a registered owner of a health product and procures the raw materials and packing components and provides the production monographs, quality control standards and procedures, but subcontract the manufacture of such product to a licensed manufacturer.
In addition, a trader may also engage in the distribution and/or marketing of its products.
Trader
Manufacturing Process:
- Formulation
- Procurement and Preparation of Raw Materials
- Production Process
- Testing and Inspection
- Storage/Warehousing
- Delivery/Distribution
Operational Requirements: These are the key areas that a manufacturer needs to establish and maintain for its operation.
Quality System
Documentation
Personnel
Premise
Equipment
Sanitation and Hygiene
Production
Quality Control
A comprehensively designed and correctly implemented to system ensure the attainment the ocofmpany’s
objectives.
Quality System
❑ A company’s quality system must
be appropriate for its current activity
A document providing a general overview of the structure and activities of the manufacturer.
Site Master File
Describe in detail the requirements with which the materials used or obtained during manufacture have to conform. They serve as a basis for quality evaluation.
Raw Material Specification
This contains all information about the manufacturing process for the product and the expected output.
This document is kept and controlled by the QA personnel.
Master Formula, Procedures, and Standards
Written instructions of the performance of specific activities.
Standard Operating Procedures
Provide evidence of various actions taken to demonstrate compliance with instructions, e.g. activities, events, investigations, and in the case of manufactured batches a history of each batch of product, including its distribution.
Records
Records include the raw data which is used to generate other records.
For electronic records, regulated users should define which data are to be used as raw data. At least, all data on which quality decisions are based should be defined as raw data.
• Develop and establish SOPs in production
• Ensure proper implementation of SOPs within the production area at all times
Production Manager
• Ensure production personnel are capacitated prior to deployment in the production area
• Ensure all areas of the production facility are well maintained
Production Manager
• Must be an Allied Health Science Professional (e.g. PRC registered pharmacist, chemist, chemical engineer, nurse, med tech, etc.)
• Establish standard operating procedures for inspection, testing and clearance of starting materials, packaging materials, intermediate, bulk and finished products;
Quality Assurance Manager
• Ensure all starting materials, packaging materials, intermediate, and finished products are of quality and within current standards
• Ensure all critical processes of the company are followed accordingly based on written procedures and policies
Quality Assurance Manager
• Keep and maintain all documents and records of the company
• Approve and monitor 3rd party testing laboratories
• Lead the conduct of internal quality audits and investigations.
Quality Assurance Manager
• Ensure that all operations of the company are in accordance with current national standards and regulations
• Ensure that all the necessary marketing authorizations are secured and up-to-date prior to operation and/or distribution of products
Qualified Person
Shall act as the point person of the company in relation to FDA-related processes
Qualified Person
Note: The Quality Assurance Manager can also serve as the Qualified Person
It shall mean any material, including printed material, employed in the packaging of product, excluding any outer packaging used for transportation or shipment, that is in direct contact with the electronic cigarette refill solution
Primary Packaging
It shall mean any material, including printed material, employed in the packaging of product, excluding any outer packaging used for transportation or shipment, that is not in direct contact with the electronic cigarette refill solution (e.g. product inserts, tags,
etc.)
Secondary Packaging
Restriction: Smoking Cessation Claims, Harm Reduction Claims
All Health Claims
Restriction:
Terms such as:
1. Light; Lites; Ultra lite
2. Supreme
3. No.1
4. Leading
5. Most
6. Finest
Potentially Misleading Content
Restriction:
Terms such as:
1. FDA-approved
2. Any mention of FDA or
3. Any mention of Philippine FDA
4. Any imitation of such words and initials
FDA Logo
Any imitation of the FDA Logo
Explicit/Implicit Conveyance of FDA Endorsement
It includes the standards for the ethical promotion of pharmaceutical product to the healthcare professionals
OPPI Guidelines
QPIRA meaning
Qualified Person in Industry Regulatory Affairs
QPIRA meaning
Qualified Person in Industry Regulatory Affairs
