Follow
1. The initiation of CAPA requires submission of the source document by concerned Department Head to QA.
2. Department Head shall decide the need for CAPA with Head QA.
3. The Department Head shall get a CAPA form issued from QA. QA shall write the source document name and Source document number on the form before issuing of form.
4. Department Head shall fill the CAPA form as under.
A) Date CAPA initiated
B) Proposed completion date
C) Select the department initiating the CAPA by making a √ mark in the appropriate box.
D) Select the relevant system affected by making a √ mark in the appropriate box. If none of the systems printed are affected select, Not applicable. If any other system other than those mentioned is affected, write the system in blank spaces provided.
E) Write in brief the CAPA description from the source document and corrective and preventive action details.
F) The Department Head shall write their name with signature and date.
5. The department head shall send the CAPA form to QA.
6. GM QA / Designee shall allot a reference number to the CAPA form and make relevant entries in the CAPA log. Forward the CAPA form to the concerned department.
7. The CAPA shall be numbered serially in the calendar year for each department with an identification code of department.
A typical CAPA form shall be numbered as
CAPA/XXX/YYY/ZZ
Where,
XXX: department code.
YYY: serial number, commencing at 001 for each department in the calendar year.
ZZ: Last digit of a calendar year.
e.g. CAPA/PRD/007/13 represents the 7th CAPA from production department in the calendar year 2013.
DEPARTMENT CODE
Prefix Department
QAD Quality Assurance Dept.
QCD Quality Control Dept.
PRD Production Dept.
WHD Ware House Dept.
ENG Engineering Dept.
HRD Human Resource Dept.
RAD Regulatory Affairs Dept.
