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Drug or Pharmaceutical SOP
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Drug or Pharmaceutical SOP
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21 cfr 210
21 cfr 210.1
21 cfr 210.2
21 cfr 210.3
21 cfr 211
211.100
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absence
adverse event
annual pqr
annual product quality review
approval
audit program
audit schedule
auditor
bait station
batch disposition
batch production record
bpr
capa
cgmp
change control
closures
complaint
complaint handling
consultant requirements
consultants
containers
contaminants
contamination
contract acceptor
contract giver
control of risks
cross contamination
customer complaint
delivery notes
disease control
distribution facilities
distribution records
distributor records
document format
documentation
documents
dress code
dress policy
drug definitions
drug distribution
drug gmp
drug gmp requirements
employee hygiene
employees
equipment
equipment cleaning
equipment construction
equipment design
equipment logboooks
equipment logs
equipment maintenance
expiry date
factory design
fmea
gdp
gdp records
gdp suppliers
gdp training
glp records
glp records and reports
gmp
gmp employees
gmp facilities
gmp facility
gmp layout
gmp production
gmp requirements
gmp suppliers
gmp training
good distribution practice
good manufacturing practice
goods-in
gxp suppliers
haccp
hand washing
head of production
head of quality
holding
holding records
hygiene training
illness
in process materials
inspection
inspector
internal audit
internal audits
investigations
lab books
lab design
lab facilities
lab notebook
lab records
lab training
labeling
labels
laboratory design
laboratory records
logbooks
management responsibilities
management training
manufacturing
manufacturing controls
master manufacturing record
material storage
materials overview
medication
mice
micro lab
mislabeling
mitigation of risks
mix-ups
mmr
organizational measures
outsourced
outsourcing
packaging
personnel
personnel overview
pest activity
pest control
pest control contractor
pest control measures
pest control specialist
pest sighting
picking
plant design
ppe
pqr
process controls
processing
product quality review
product recall
product returns
production
production facilities
production facility
production management
production manager
production overview
production records
purchase order
qa
qa management
qa manager
qa records
qa reports
qa responsibilities
qcu
qms
qms overview
qms records
qms records and reports
qms requirements
qms responsibilities
qms training
qp
qrm
qualifications
qualified person
quality assurance
quality control unit
quality management system
quality risk management
quarantine
radiological lab
raw materials
recall
receipt of materials
record format
record keeping
records
records and reports
release of materials
reports
representative samples
reprocessing
responsible person
retailer complaint
return
returns
rework
risk
risk assessment
risk assessments
risk based approach
risk procedure
risk review
rodent
salvage
salvaging
sampling
self-inspection
sickness
site design
smoking
sop format
storage
storage conditions
supplier agreement
supplier approval
supplier control
supplier qualification
supply agreement
supply chain
technical agreement
technical measures
testing
traceability
training
warehouse construction
warehouse design
warehouse facilities
warehouse records
wholesale distribution
wholesale distribution authorisation
wholesale distribution authorization
wholesale distributor
Select and download an SOP for instant FDA 21 CFR 211 Drug GMP and European Pharmaceutical GMP Eudralex or Orange Guide compliance.
All our procedures are in Microsoft Word format and are fully editable to add your company logo, design, and business specific wording. They include a competency test to serve as a record of training for personnel.