Parameters to be c#ecked Stores (Raw Materials ' Packin Materials!
&
a b c d e f g
Whether approved vendor list is available and followed? Whether materials purchased as per vendor list? Whether the material stored as per its required storage conditions. Whether materials are segregated / stored and handled safely. Is there a proper identification / location for each materials stored? Whether the status of the material is clearly identified and labeled? Is there proper segregation of materials as Quarantine / A pproved & e!ected?
h
Are all safety instructions followed for materials?
i
Whether materials are stored securely?
! "
a
b
c
d
Is there counterfeiting control system available while material is under transfer? Whether the material storage conditions are maintained through out its processing stage? Raw Materials Dispensin Whether the sampling of aw materials is carried out strictly as per #$%? Whether line clearance procedure is followed for product to product change over strictly to avoid cross contamination? Whether '$ / I$ system is followed for raw materials and raw materials to be dispensed? Whether aw materials ta"en for dispensing is chec"ed for approval / retest / use before date status before dispensing?
( ) % a g e
$bser%ation
Remarks
Sl" No" e
f
g
h i ! "
Parameters to be c#ecked
$bser%ation
Remarks
Whether the Weighing )alances used for dispensing is chec"ed for calibration status / calibrated before dispensing activity. Whether the dispensing is carried out under clean environment / under dispensing booth? Whether the employees follow secondary dress discipline and handle dispensing with personal protective equipments li"e* gloves / mas" etc.*? Whether dedicated scoops are being used for active raw materials to be dispensed? Whether a single material ta"en for dispensing at a time? Whether the dispensed material is sealed and labeled with proper dispensing label? Whether the dispensed materials are stored safely with authori+ed handling and control? Packin Materials Dispensin
*
a b c d e
f
g h
Whether the %rinted %ac"ing materials are stored with proper segregation securely? Whether the sampling of %ac"ing materials is carried out strictly as per #$%? Whether the line clearance procedure is followed for printed pac"ing material dispensing? Whether I$ system is followed for pac"ing materials? Whether %ac"ing materials ta"en for dispensing are chec"ed for approval status before dispensing? Whether a single material is ta"en for dispensing at a time? Whether the %rinted %ac"ing materials are dispensed under authori+ed person one by one to avoid mi,-ups? Whether the dispensed material is labeled with proper dispensing label? Whether the dispensed materials are stored safely with authori+ed handling and control? Assessment Done +y:
Whether employees are sub!ected to %re-employment medical chec"up before appointment? Whether employees are sub!ected to medical chec"up b periodically there after? a
c
Whether employees are trained for their specific !ob?
d
Whether the employees are provided with safety apparels for their specific !ob?
e
Whether the employees are assessed for competency?
Whether the employee-to-employee designationwise0 reporting procedure is followed? Whether there is a proper communication between g employee and reporting boss and also between shifts? Is irst Aid facility provided to the wor"ing personnel h and are they trained? f
Assessment Done +y:
1 ) % a g e
,#ecked +y:
Appro%ed +y:
Department
:
Product Name: Subject : .uipments
Sl" No"
Parameters to be c#ecked
$bser%ation
Remarks
Are 'quipments master list available for all departments? b Are 'quipments coded? a
c d e f g h i ! " l m n o p q r s
Are 'quipments supplied with safety features? Are 'quipments of 23% model with product contact parts made up of ##1(4? Are 'quipments contact parts are tested for ##1(4? Are 'quipments earthed? Are the electrical lines / wirings of all 'quipments concealed and safe for operation? Are 'quipments provided with safety doors or0 machine guards* emergency off switch etc.*? Are 'quipments cleaned as per schedule? Are 'quipments sub!ected to cleaning verification during product to product changeover? Are all 'quipments in use labeled with the adequate status label? Are safety instructions for operation of 'quipments included in #$%5s? Is equipment5s master calibration list available? Are equipments calibrated as per schedule and reports available? Are equipments qualified for 6esign* Installation* $peration and %erformance 6Q* IQ* $Q & %Q0? Is equipment5s planned preventive maintenance schedule available? Is preventive maintenance carried out for all critical equipments and reports available? Are filters of A78 units cleaned as per schedule and reports available? Are equipments free from noise and noise level is with in the noise control limits? Assessment Done +y:
9 ) % a g e
,#ecked +y:
Appro%ed +y:
Department
:
Product Name: Subject : 0acilities
Sl" No" a b c d e f g h
i
! " l
m
n
o p
q
Parameters to be c#ecked
$bser%ation
Remarks
Is Approved site master plan available and updated? Is Approved site layout drawing for all the floors available and updated? Is #ite construction / area qualification done and protocol / reports available? Are all the critical manufacturing areas supplied with dedicated Air 7andling 8nits? Are 3aterial and 3en movements clearly defined for all the critical manufacturing operations? Are required utilities connected in all the areas and are wor"ing condition satisfactory? Are equipments utilities are colour coded / labeled and flow direction is indicated? Are utilities lines lea" proof and is lea"age observed in any section? Is floor / wall / ceiling integrity including painting structure0 maintained for all sections in critical manufacturing areas? Is there proper lightening system for all sections and lu, level for the same is within the limits? Are doors of all critical operations in wor"ing condition and door discipline maintained? Is building maintenance wor" carried out on regular basis? Is :on-routine wor" to return to routine wor" procedure followed during building maintenance wor" and reported? Are all the departments provided with fire fighting equipments and can be accepted for safe operations? Are all the floors provided with emergency evacuation doors with escape route directions? Are fire alarm system provided for all critical operations? Whether the tamper proof system is available in manufacturing / pac"ing of products to avoid any misuse or0 mischief? Assessment Done +y:
; ) % a g e
,#ecked +y:
Appro%ed +y:
Department
:
Product Name: Subject : .n%ironment ,ontrol
Sl" No" a b c d e f g h i ! " l m n o
Parameters to be c#ecked
$bser%ation
Remarks
Is cleaning and disinfection schedule available for all critical operations? Is cleaning and disinfection carried out for all sections as per schedule? Is disinfection validation carried out for all disinfectants used in site and reports available? Are the critical manufacturing areas clean and suitable for hygienic operations? Is temperature controlled / monitored and reported for all critical manufacturing operations? Is humidity controlled / monitored and reported for all critical manufacturing operations? Is pressure differential for critical manufacturing operations controlled / monitored and reported? Is pest control schedule available in the site? Is pest control carried out outside the premises and away from critical operations? Is pest control carried out as per the schedule and reported? Is there any possibility for cross contamination with respect to ad!acent area operations? Is there any possibility for cross contamination with respect to 3en movements? Is there any possibility for cross contamination with respect to 3aterial movements? Is microbiological monitoring of air carried out on routine basis and are trend results satisfactory? Is microbiological monitoring of water carried out on routine basis and are trend results satisfactory? Assessment Done +y:
4 ) % a g e
,#ecked +y:
Appro%ed +y:
Department
:
Product Name: Subject : Met#od and Procedures
Sl" No" a b c d e f g h i ! " l m n o p q
r
Parameters to be c#ecked Is #$% for #$% available and followed? Are #$%s available for all critical operations? Are #$%s distributed by QA and displayed for all operations? Are #$%s reviewed? Is Approved 3aster validation plan available and updated? Is current version Approved product master formula record available and followed? Is master formula record and site batch record )3/)%0 matching and verified? Are current aw material and %ac"ing material specification for the product available / followed? Are current version of intermediate / finished product specifications available and followed? Is the current version of Artwor" copy and printed pac"ing material instructions available for the product? Are %%I* Artwor"* specification of raw materials and finished products regulatory complied? Are current version of product quality standards and method of analysis available? Is product process validation carried out and are compiled reports available? Is air supplied by A78s to various sections validated and validation reports available? Is water supplied by $ %lant to various sections v alidated and validation reports available? Is compressed air supplied by compressor to various sections validated and validation reports available? Is product analytical method validation carried out an d reports available? Is change control system followed for all change in process / facility / equipment and documents and are reports available?
< ) % a g e
$bser%ation
Remarks
Sl" No" s
t u
v
w
,
y
+
Parameters to be c#ecked
$bser%ation
Remarks
Is change control register maintained and any change control raised in documentation reflected in )atch ecord? Is deviation control system followed for deviations in product processing and are they documented? Is QA inprocess control in place for chec"s on all critical quality parameters of the product? Is intermediate / finished products tested by Q= and reported / approved before finished products release? Is finished product release procedure followed? Are batch records / Q= reports reviewed before product release? Is record room for retention of documents available and provided with pest control monitoring and free from fire ha+ards? Is record room arranged with documents product wise* batch no. wise and year wise in an orderly manner? And are documents easily traceable? Is documents retention period and destruction after retention time followed? Assessment Done +y:
