SOPs
Pharma Industry Guidelines
SOP For Line Clearance
Objective:
To lay
down the procedure for the line clearance of the area / equipment.
2. Scope:
This SOP is applicable to all stages of manufacturing operations carried out before the start of operation/stage during the manufacturing/packing to avoid any...
Pharma Industry Guidelines
SOP for Sampling
1.Objective :
To lay down the procedure for sampling of
intermediates, drug substances, drug products.
2. Scope :
This procedure is applicable for
Pharmaceutical Industry of API as well as formulations.
3. Definition :
Sample:
Sample
is a portion of...
Pharma Industry Guidelines
SOP- Responsibility of Production Dept.
1.Objective :
To define the responsibilities of Production Department.
2. Scope:
This procedure is applicable to all
personnel working in Production Department.
3. Responsibilities :
Microbiology Person / Designee, Microbiology Head
4. Procedure :
Strict adherence to approved
procedures.To ensure Good
Manufacturing Practices.To follow...
Microbiology
SOP- Responsibility of Microbiology Dept.
1.Objective :
To define the responsibilities of Microbiology
Department.
2. Scope:
This procedure is applicable to all
personnel working in Microbiology Department.
3. Responsibilities :
Microbiology Person / Designee, Microbiology Head
4. Procedure :
Strict adherence to approved
procedures.To ensure Good Laboratory
Practices.To follow good
documentation...
Pharma Industry Guidelines
SOP – Planned Modification
1.Objective:
To
lay down the procedure for
handling of Planned Modification System.
2. Scope :
This
SOP is applicable to addition, deletion &/or modification of area,
equipments, utility, system, machines.
3. Responsibilities :
User
Department, QA, Engineering
4. Definitions:
Planned
Modification: A modification which
is planned for...
Pharma Industry Guidelines
Engineering SOP -FAT : Factory Acceptance Test & SAT : Site Acceptance Test
Factory Acceptance Test (FAT)
Inspection and static
&/or dynamic testing of system or major system component to support the
qualification of an equipment/system conducted & documented at a supplier
siteEstablishing documented
evidence that the vendor fabrication process or material...
Pharma Industry Guidelines
SOP: Handling of Returned Goods
1.Objective :
To lay down the procedure for handling of returned goods from distributor / customer end.
2. Scope:
This procedure is applicable for identifying, holding and/or disposition of Drugs Product & Drug Substances returned from...
Pharma Industry Guidelines
SOP : Responsibilities of Quality Control Dept.
1.Objective :
To define the
responsibilities of Quality Control Department.
2. Scope :
This procedure is
applicable to all the personnel working in Quality Control Dept.
3. Responsibilities :
QC Analyst, QC in
Charge, Lab Technicians, QC Reviewer, QC Section Head,...