Personnel Movement, Purpose:
Personnel Movement, To define the procedure to be applied for the movement of people & transfer of documents & materials between Cephalosporin & General block.
Personnel Movement, Scope:
This document lays down the guidelines for the movement of people & transfer of documents & materials between the Cephalosporin & General block of XX Pharmaceuticals Limited.
Definitions / Abbreviation:
[][]QC – Quality Control
[][]QA- Quality Assurance
[][]QA – Quality Assurance
[][]SOP – Standard Operating Procedure
Responsibilities:
[][]The roles and responsibility is as follows:
All Concerned Personnel
[][]To be responsible to follow the SOP
General Manager, Plant
[][]Proper follow-up of overall activities
Manager, Quality Assurance
[][]Responsible to ensure the Assurance to the procedure.
Procedure:
[][]Where the need arises to move or to transfer documents & materials between the Cephalosporin and General block, care should be taken to prevent contamination, to eliminate the potential sources of contamination. Following provisions have to be maintained in such cases:
Movement of people
[][]Entry of the people working in the Cephalosporin Block is restricted to the General Block during or after their working time. They can enter General Block only before entering the Cephalosporin Block as per requirement.
[][]People working in the General Block can enter into the Cephalosporin Block at any time as per requirement. But it should be maintained that they will not enter again into the General Block at that day.
[][]To transfer any documents / samples / tools / equipment from the General Block to the Cephalosporin Block, the assigned personnel will handover that to the person who work at the lobby area of Cephalosporin Block.
[][]The people working in the lobby area will then handover those to the persons inside the change room.
Transfer of Documents
[][]All the master documents related with Cephalosporin block will be preserved in the document archive room of Cephalosporin Block.
Issuing of BMR, BPR, Logbooks, Forms etc. which control is in the General Block will be done after receiving the requisition from the concerned department to Quality Assurance.
[][]But all the requisition will be performed electronically through mail.
[][]Some common SOPs are shared both by Cephalosporin & General Block. In such cases, all the master copies will be preserved in AGM, QA room of the General Block and controlled copies will be distributed in the Cephalosporin Block.
[][]All signatories will be taken within the Cephalosporin Block.
[][]No documents are allowed to be transferred from the Cephalosporin Block to the General Block. If any document is necessary to be sent to the General Block from Cephalosporin Block (e.g. atomic absorption spectrophotometer reading) it will be sent as an information copy through fax or scan or as a form of soft copy through LAN / Internet.
[][]Before the transfer of materials, the required amount of material is collected & to be placed on a pallet. The material is then transferred manually from General warehouse to the receiving bay of the Cephalosporin warehouse. From the receiving bay, the material is transferred to another pallet (dedicated for Cephalosporin block).
[][]For washed & dried glass bottle or crushed sucrose the same procedure stated in above will be followed.
[][]The pallets/ HDPE drums which were used for transferring materials from the General warehouse can be used only after proper cleaning. These pallets must not be used in the production floor; they will be used only in the warehouse.
[][]For analytical purpose, a set of reference / working standard which is required for analysis must be available in the Cephalosporin QC/ Microbiology laboratory.
[][]Product Development Activities: Any kind of process or product development work related with Cephalosporin product must be conducted within the Cephalosporin block.
[][]Engineering Activities: Any kind of maintenance, calibration activities will be done by the dedicated personnel and equipment’s. In case of single calibration instruments, after finishing the tasks at Cephalosporin Block, all the equipment’s will be transferred to Calibration lab. after proper cleaning and de-contamination.
Annexure:
Annexure I- Inter Departmental Materials Transfer Record
Annexure II- Status Label for Inter Departmental Transferred Materials