Standard operating procedures (SOPs) Flashcards
what percentage of drug shortages resulted from quality concerns while relying on incorrect SOPs
40%
what are SOPs
set of step by step procedure or chronological written instructions intended to perform a routine activity & to document.
What are other names for SOPs
protocols, Instructions, Worksheets and laboratory operating procedures (LOP).
what is the primary purpose of SOPs as per regulatory authorities?
To ensure compliance with regulatory requirements. achieve defined objectives and maintain documeted systems and procedures for inspection and reference
Which rules in schedule M of the Drugs and Cosmetics Act relate to SOPs?
Rules 71, 74, 76 and 78 specify the need for documented systems and procedures in manufacturing premises
What does US FDA CFR Part 211, Subpart F 211.100 state about SOPs?
it requires written procedures for productiion and process control, including documentation of any deviations from these procedures.
What does CFR Part 820 emphasize regarding SOPs?
Firms must “establish and maintain procedures to ensure quality systems are in place for medical devices
What steps must companies take to comply with SOP requirements?
Define procedures
Document them (on paper or electronically)
implement them
review and review as needed
How often should SOPs be reviewed and revised?
SOPs should be reviewed and revised as needed to reflect current practices, regulatory updates, and improvements in processes
What does ISO 9001-2008, Clause 4.2 state about documented procedures?
requires that documented procedures be established, documented, implemented and maintained.
What is the focus of IS/ISO 14001:2004, Clause 4.5.4?
it requires organizations to establish, implement, and maintain procedures for the identification, storage, protection, retrieval, retention, and disposal of records.
What does IS 18001:2007, Clause 4.4.5 emphasize regarding document control?
It requires organizations to establish, implement, and maintain procedures for controlling all documents required by the Occupational Health and Safety (OH&S) management system and the standard.
Why did PharMEDium Services, LLC recall 25,327 units of drug products?
Due to a lack of assurance of sterility, which could compromise patient safety.
What issue led Sun Pharmaceutical Industries, Inc. to recall 2 lots of Riomet®?
Contamination with Scopulariopsis brevicaulis, a fungal pathogen, posing a risk to patient health.
Why did Bella Pharmaceuticals recall all lots of unexpired drug products?
Due to a lack of sterility assurance, which could result in unsafe products reaching patients.
What was the reason for Vital Rx, Inc.’s recall of compounded injectable medications?
A lack of sterility assurance, which could lead to infections or other adverse effects in patients.
Why did Hospira, Inc. recall one lot of 25% Dextrose Injection, USP?
Due to the presence of particulate matter, which could cause blockages or other complications if administered to patients.
What led Isomeric Pharmacy Solutions to recall all lots of sterile products within expiry?
A lack of sterility assurance, which could compromise the safety and efficacy of the products.
What writing style is recommended for SOPs?
Use the active voice and present tense to make instructions clear and direct.
How should long procedures with more than 10 steps be formatted?
They should be written with graphical formats or hierarchical steps. Example: Entry/Exit procedure.
How should procedures requiring many decisions be formatted?
They should include a flowchart to guide decision-making. Example: SOP for deviation management.
Is there an FDA-approved format for SOPs?
No, there is no FDA-approved format for SOPs. However, they must be clear, concise, and follow regulatory guidelines.
What should be included in the general part of an SOP?
Title page
Company logo on all pages
Header with SOP title
Department name
Effective date
Revision date
Review date
Page number
SOP number/identification number
Reference documents
What should be included in the content part of an SOP?
Purpose
Scope
Responsibilities and accountabilities
Procedure
What should be included in the footer of an SOP?
Approving signatures:
✓ Prepared by
✓ Checked by
✓ Approved by
Stamp (e.g., Controlled Copy/Master Copy QA Stamp)
How many characters does an SOP number typically consist of?
Seven alphanumeric characters (e.g., CGO-001).
What does the 1st alpha character in an SOP number represent?
It indicates the location code (e.g., a specific site or facility).
What does the 2nd alpha character in an SOP number represent?
It indicates the department code (e.g., QA for Quality Assurance).
What does the 3rd alpha character in an SOP number represent?
It indicates the subsection/area code within the department.
What is the purpose of the 4th character (dash ‘-’) in an SOP number?
It acts as a separator between the alphanumeric and numeric parts of the SOP number.
What do the 5th, 6th, and 7th numerical characters in an SOP number represent?
They indicate the serial number of the SOP within that department.
What would the SOP number CGO-001 represent?
C: Location code
G: Department code (e.g., QA)
O: Subsection/area code
001: First SOP in that department
