- OBJECTIVE:
To lay down a procedure for Preparation of Technical Staff List.
- SCOPE:
This SOP is applicable for preparation of technical staff list at {Company Name} {Company Location}.
- RESPONSIBILITY:
- QA officer/executive/Designee- Follow the instruction as per procedure.
- QA Executive/Designee-Review and technical correction of SOP.
- ACCOUNTABILITY:
QA Head shall be accountable for the implementation of SOP.
- PROCEDURE:
- QA Executive/Designee shall prepare the list of technical staff as per Annexure-I.
- The annexure-I shall contain List No, Effective Date, Review Before, Revision No, Name, Designation, Department, Qualification and Experience.
- Technical staff list shall be prepared by QA officer/executive/Designee, reviewed by QA Sr. executive/Designee and above and approved by QA head/Designee.
- The technical staff list number shall be assigned as: AAA/BB/LT/001.
Where:
| AAA | : | Indicates to Company Name |
| BB | : | Indicates to Department Name |
| LT | : | Indicates to List of Technical Staff |
| / | : | Indicates to Separator |
| 001 | : | Indicates to Serial Number for Technical Staff List. |
- The list of technical staff shall update at least twice in a year or as whenever required.
- If any technical staff leaves the company, then the technical staff list should be updated within two months.
- REFERENCES:
Not Applicable
- ANNEXURES:
| ANNEXURE No. | TITLE OF ANNEXURE |
| Annexure- I | List for technical staff |
- DISTRIBUTION:
| Controlled Copy No. 01 | : | Head Quality Assurance |
| Controlled Copy No. 02 | : | Head Quality Control |
| Controlled Copy No. 03 | : | Head Production |
| Master Copy | : | Quality Assurance Department |
- ABBREVIATIONS:
| SOP | : | Standard Operating Procedure |
| No. | : | Number |
| QA | : | Quality Assurance |
| 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
LIST OF TECHNICAL STAFF
| List No.: | Effective Date : | ||
| Revision No.: | Review Before : |
| S. NO. | NAME | DESIGNATION | DEPARTMENT | QUALIFICATION | EXPERIENCE |
Frequently Asked Questions?
1. What information should be included in a technical staff list?
- Basic personal information: Name, contact details, department/team
- Job title and role: Specific technical function(s) within the department
- Qualifications and experience: Education, relevant certifications, years of experience in the industry and specific area
- Technical skills and expertise: Specific equipment/software proficiency, areas of specialization
- Regulatory knowledge: Familiarity with relevant regulatory agencies and guidelines (e.g., FDA, EMA)
- Language skills: Fluency in languages applicable to the role or company operations
2. How to determine which information is most relevant to include?
- Consider the purpose of the list: Is it for internal reference, regulatory compliance, collaboration with partner organizations, or something else?
- Tailor the content to the specific audience who will be using the list.
- Strike a balance between providing enough information to be useful and respecting individual privacy.
3. What are some best practices for formatting and updating the list?
- Use a clear and organized layout for easy navigation and readability.
- Standardize terminology and abbreviations for consistency.
- Maintain the list electronically for easy updates and version control.
- Establish a regular review and update schedule to ensure accuracy and relevance.
4. What potential challenges or considerations are there when preparing the list?
- Data accuracy: Ensure information is up-to-date and verified from authorized sources.
- Privacy concerns: Balance transparency with employee data protection, especially sensitive information.
- Compliance with regulations: Ensure the list format and content adheres to relevant industry and regulatory requirements.
- Confidentiality: Consider restricting access to the list based on need-to-know principles.
5. Are there any helpful tools or resources for preparing technical staff lists?
- HR management software often includes features for employee data management and list creation.
- Some industry organizations or regulatory agencies may provide templates or guidelines for specific types of lists.
- Utilize online collaboration tools to facilitate data gathering and editing from team members.
6. Why technical staff list is important ?
Every step in the pharmaceutical manufacturing process must be traceable and performed by qualified personnel. Having a detailed staff list readily available allows for proper assignment of tasks based on relevant expertise and facilitates accountability in case of any issues.
