gmp quality assurance and validation procedures 2
TRANSCRIPT
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Fcn`cg ]gsfw}og fc Bffk Dlcwhlo{w}`cb Y}lo{`og# Ywmn`segk `c rrr#bdysfy#ofd
Ofyp}`be{=9
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Fcn`cg ]gsfw}og fc Bffk Dlcwhlo{w}`cb Y}lo{`og# Ywmn`segk `c rrr#bdysfy#ofd
Ofyp}`be{=9
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Fcn`cg ]gsfw}og fc Bffk Dlcwhlo{w}`cb Y}lo{`og# Ywmn`segk `c rrr#bdysfy#ofd
Ofyp}`be{=9
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Fcn`cg ]gsfw}og fc Bffk Dlcwhlo{w}`cb Y}lo{`og# Ywmn`segk `c rrr#bdysfy#ofd
Ofyp}`be{=9
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Fcn`cg ]gsfw}og fc Bffk Dlcwhlo{w}`cb Y}lo{`og# Ywmn`segk `c rrr#bdysfy#ofd
Ofyp}`be{=9
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Fcn`cg ]gsfw}og fc Bffk Dlcwhlo{w}`cb Y}lo{`og# Ywmn`segk `c rrr#bdysfy#ofd
Ofyp}`be{=9
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Fcn`cg ]gsfw}og fc Bffk Dlcwhlo{w}`cb Y}lo{`og# Ywmn`segk `c rrr#bdysfy#ofd
Ofyp}`be{=9
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Fcn`cg ]gsfw}og fc Bffk Dlcwhlo{w}`cb Y}lo{`og# Ywmn`segk `c rrr#bdysfy#ofd
Ofyp}`be{=9
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Fcn`cg ]gsfw}og fc Bffk Dlcwhlo{w}`cb Y}lo{`og# Ywmn`segk `c rrr#bdysfy#ofd
Ofyp}`be{=9
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Fcn`cg ]gsfw}og fc Bffk Dlcwhlo{w}`cb Y}lo{`og# Ywmn`segk `c rrr#bdysfy#ofd
Ofyp}`be{=9
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Fcn`cg ]gsfw}og fc Bffk Dlcwhlo{w}`cb Y}lo{`og# Ywmn`segk `c rrr#bdysfy#ofd
Ofyp}`be{=9
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Fcn`cg ]gsfw}og fc Bffk Dlcwhlo{w}`cb Y}lo{`og# Ywmn`segk `c rrr#bdysfy#ofd
Ofyp}`be{=9
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Fcn`cg ]gsfw}og fc Bffk Dlcwhlo{w}`cb Y}lo{`og# Ywmn`segk `c rrr#bdysfy#ofd
Ofyp}`be{=9
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Fcn`cg ]gsfw}og fc Bffk Dlcwhlo{w}`cb Y}lo{`og# Ywmn`segk `c rrr#bdysfy#ofd
Ofyp}`be{=9
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Fcn`cg ]gsfw}og fc Bffk Dlcwhlo{w}`cb Y}lo{`og# Ywmn`segk `c rrr#bdysfy#ofd
Ofyp}`be{=9
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Fcn`cg ]gsfw}og fc Bffk Dlcwhlo{w}`cb Y}lo{`og# Ywmn`segk `c rrr#bdysfy#ofd
Ofyp}`be{=9
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Fcn`cg ]gsfw}og fc Bffk Dlcwhlo{w}`cb Y}lo{`og# Ywmn`segk `c rrr#bdysfy#ofd
Ofyp}`be{=9
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Fcn`cg ]gsfw}og fc Bffk Dlcwhlo{w}`cb Y}lo{`og# Ywmn`segk `c rrr#bdysfy#ofd
Ofyp}`be{=9
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Fcn`cg ]gsfw}og fc Bffk Dlcwhlo{w}`cb Y}lo{`og# Ywmn`segk `c rrr#bdysfy#ofd
Ofyp}`be{=9
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Fcn`cg ]gsfw}og fc Bffk Dlcwhlo{w}`cb Y}lo{`og# Ywmn`segk `c rrr#bdysfy#ofd
Ofyp}`be{=9
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Fcn`cg ]gsfw}og fc Bffk Dlcwhlo{w}`cb Y}lo{`og# Ywmn`segk `c rrr#bdysfy#ofd
Ofyp}`be{=9
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Fcn`cg ]gsfw}og fc Bffk Dlcwhlo{w}`cb Y}lo{`og# Ywmn`segk `c rrr#bdysfy#ofd
Ofyp}`be{=9
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Fcn`cg ]gsfw}og fc Bffk Dlcwhlo{w}`cb Y}lo{`og# Ywmn`segk `c rrr#bdysfy#ofd
Ofyp}`be{=9
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Fcn`cg ]gsfw}og fc Bffk Dlcwhlo{w}`cb Y}lo{`og# Ywmn`segk `c rrr#bdysfy#ofd
Ofyp}`be{=9
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Fcn`cg ]gsfw}og fc Bffk Dlcwhlo{w}`cb Y}lo{`og# Ywmn`segk `c rrr#bdysfy#ofd
Ofyp}`be{=9
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Fcn`cg ]gsfw}og fc Bffk Dlcwhlo{w}`cb Y}lo{`og# Ywmn`segk `c rrr#bdysfy#ofd
Ofyp}`be{=9
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Fcn`cg ]gsfw}og fc Bffk Dlcwhlo{w}`cb Y}lo{`og# Ywmn`segk `c rrr#bdysfy#ofd
Ofyp}`be{=9
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Fcn`cg ]gsfw}og fc Bffk Dlcwhlo{w}`cb Y}lo{`og# Ywmn`segk `c rrr#bdysfy#ofd
Ofyp}`be{=9
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Fcn`cg ]gsfw}og fc Bffk Dlcwhlo{w}`cb Y}lo{`og# Ywmn`segk `c rrr#bdysfy#ofd
Ofyp}`be{=9
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Fcn`cg ]gsfw}og fc Bffk Dlcwhlo{w}`cb Y}lo{`og# Ywmn`segk `c rrr#bdysfy#ofd
Ofyp}`be{=9
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Fcn`cg ]gsfw}og fc Bffk Dlcwhlo{w}`cb Y}lo{`og# Ywmn`segk `c rrr#bdysfy#ofd
Ofyp}`be{=9
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Fcn`cg ]gsfw}og fc Bffk Dlcwhlo{w}`cb Y}lo{`og# Ywmn`segk `c rrr#bdysfy#ofd
Ofyp}`be{=9
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Fcn`cg ]gsfw}og fc Bffk Dlcwhlo{w}`cb Y}lo{`og# Ywmn`segk `c rrr#bdysfy#ofd
Ofyp}`be{=9
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Fcn`cg ]gsfw}og fc Bffk Dlcwhlo{w}`cb Y}lo{`og# Ywmn`segk `c rrr#bdysfy#ofd
Ofyp}`be{=9
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Fcn`cg ]gsfw}og fc Bffk Dlcwhlo{w}`cb Y}lo{`og# Ywmn`segk `c rrr#bdysfy#ofd
Ofyp}`be{=9
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Fcn`cg ]gsfw}og fc Bffk Dlcwhlo{w}`cb Y}lo{`og# Ywmn`segk `c rrr#bdysfy#ofd
Ofyp}`be{=9
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Fcn`cg ]gsfw}og fc Bffk Dlcwhlo{w}`cb Y}lo{`og# Ywmn`segk `c rrr#bdysfy#ofd
Ofyp}`be{=9
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Fcn`cg ]gsfw}og fc Bffk Dlcwhlo{w}`cb Y}lo{`og# Ywmn`segk `c rrr#bdysfy#ofd
Ofyp}`be{=9
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Fcn`cg ]gsfw}og fc Bffk Dlcwhlo{w}`cb Y}lo{`og# Ywmn`segk `c rrr#bdysfy#ofd
Ofyp}`be{=9
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Fcn`cg ]gsfw}og fc Bffk Dlcwhlo{w}`cb Y}lo{`og# Ywmn`segk `c rrr#bdysfy#ofd
Ofyp}`be{=9
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Fcn`cg ]gsfw}og fc Bffk Dlcwhlo{w}`cb Y}lo{`og# Ywmn`segk `c rrr#bdysfy#ofd
Ofyp}`be{=9
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Fcn`cg ]gsfw}og fc Bffk Dlcwhlo{w}`cb Y}lo{`og# Ywmn`segk `c rrr#bdysfy#ofd
Ofyp}`be{=9
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Fcn`cg ]gsfw}og fc Bffk Dlcwhlo{w}`cb Y}lo{`og# Ywmn`segk `c rrr#bdysfy#ofd
Ofyp}`be{=9
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Fcn`cg ]gsfw}og fc Bffk Dlcwhlo{w}`cb Y}lo{`og# Ywmn`segk `c rrr#bdysfy#ofd
Ofyp}`be{=9
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Fcn`cg ]gsfw}og fc Bffk Dlcwhlo{w}`cb Y}lo{`og# Ywmn`segk `c rrr#bdysfy#ofd
Ofyp}`be{=9
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Fcn`cg ]gsfw}og fc Bffk Dlcwhlo{w}`cb Y}lo{`og# Ywmn`segk `c rrr#bdysfy#ofd
Ofyp}`be{=9
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Fcn`cg ]gsfw}og fc Bffk Dlcwhlo{w}`cb Y}lo{`og# Ywmn`segk `c rrr#bdysfy#ofd
Ofyp}`be{=9
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Fcn`cg ]gsfw}og fc Bffk Dlcwhlo{w}`cb Y}lo{`og# Ywmn`segk `c rrr#bdysfy#ofd
Lwk`{`cb lc Guo`y`gc{ _wyyn`g}
Re`ng {eg}g `s cf s`cbng }gbwnl{f}p kfowdgc{ r`{e {eg {g}d -guo`y`gc{- `c `{s cldg lck {eg}gl}g cf }gbwnl{f}p }g|w`}gdgc{s {el{ guo`y`gc{s mg dlcwhlo{w}gk {f BDYs f{eg} {elc hf}{efsg guo`y`gc{ ol{gbf}`gs sygo`h`gk `c GW ngb`snl{`fc. {eg}g l}g xfnwc{l}p `ckws{}p s{lckl}ks{el{ b`xg bw`klcog hf} lyynp`cb lyy}fy}`l{g BDY y}`co`yngs {f guo`y`gc{s# [egsg bw`klcogs`conwkg {efsg kfowdgc{s wsgk mp {eg @c{g}cl{`fcln F}blc`ql{`fc hf} _{lckl}k`ql{`fc %@_F).Rf}nk Egln{e F}blc`ql{`fc %REF). lck {eg @c{g}cl{`fcln Yel}dlogw{`oln Guo`y`gc{ Ofwco`n
%@YGO)#
Lwk`{`cb lc F}ln _fn`k _fnw{`fc L}glLc f}ln kfslbg hf}d dlp mg g`{eg} l n`|w`k f} l sfn`k# Gloe hf}d wsgs k hhg}gc{dlcwhlo{w}`cb y}fogssgs lck g|w`ydgc{# [e`s `s `dyf}{lc{ {f lc lwk`{f} mgolwsg sfdg`{gds {el{ l}g o}`{`oln `c fcg fyg}l{`fc dlp cf{ mg o}`{`oln {f lcf{eg}#