SOP on Disposal of Non-Recoverable In-process Materials

April 5, 2016September 11, 2024 Pharmaceutical Guidanace

SOP on Disposal of Non-Recoverable In-process Materials

Objective: To lay down a procedure for disposal of non-recoverable in-process materials.

Scope: The standard operating procedure is applicable for formulation plant of Pharmaceutical Company name with location.

Responsibility

Production-Supervisor / Officer shall be responsible for implementation of this SOP.

Production-Head / designee shall be responsible for compliance of this SOP.

Abbreviations and Definitions

SOP – Standard Operating Procedure

PVC – Polyvinyl Chloride

ETP – Effluent Treatment Plant

SS- Stainless Steel

QA – Quality Assurance

Procedure

Procedure in various manufacturing sections.

Rejected non-recoverable in-process products shall be destroyed by dispersing / dissolving in sufficient quantity of potable water (not less than 2 times the material volume) in a SS or PVC container labeled with ‘SCRAP’ and then transferring to ETP area.

Disposal of rejected tablets / capsules: Rejected tablets and capsules during the initial run from compression machine and capsule machine respectively, or from any non-conformance necessitating rejection, shall be destroyed as per the point no. 5.1.1.

Disposal of rejected ointment / gel / oral liquids: Rejected ointment / gel during the initial run from filling machines or from any non-conformance necessitating rejection, shall be destroyed as per point no. 5.1.1. For oral liquids, this shall be collected in SS container labeled with ‘SCRAP’ and shall be drained to ETP connected drains.

Disposal of dust: Dust collected from vacuum cleaner / dust extractor is destroyed as per point no. 5.1.1.

Procedure in various Packaging Sections.

Remove the Tablets / Capsules from the rejected Blisters / strips, defoil the strips / Blisters and destroy the same as per point 5.1.1

Forms and Records

Not Applicable

Distribution

Master Copy – Documentation Cell (QA)

Controlled Copies – Production, Quality Assurance, Administration and Housekeeping

History

Date	Revision Number	Reason for revision
–	00	New SOP

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Dnipropetrovsk, Ulhasnagar, Ulyanovsk, Umm al-Qaiwain, Umm al-Quwain, Umm Bab, Umm Birka, Umm Ghuwailina, Umm Lekhba, Umm Qarn, Umm Salal Ali, Umm Salal Mohammed, United arab emirates, UNITED ARAB EMIRATES (UAE), united Kingdom, UNITED KINGDOM* (UK), United States, UNITED STATES OF AMERICA (USA), URUGUAY, UZBEKISTAN, Vadodara, VADUZ, Vale of Glamorgan, Valencia, VALLETTA MARSHALL ISLANDS, VANUATU, Varanasi, Varese, Vasai Virar, VATICAN CITY, VATICAN CITY (Holy See), VENEZUELA CARACAS, Venice, Verbano-Cusio-Ossola, Vercelli, Verona, Vibo Valentia, Vicenza, Victoria, Vienna, VIENTIANE, VIETNAM HANOI, Vijayawada, VILNIUS, Visakhapatnam, Viterbo, Vladimir, Volgograd, Vologda, Voronezh, Wadi Al Banat, Wadi Al Sail, Wadi Al Wasaah, Wadi Lusail, Wakefield, Wales, Warrington, Warsaw, Warwickshire, Washington, Wellington, Wells, West Berkshire, West Dunbartonshire, West Lothian, West Midlands, West Sussex, West Yorkshire, West Yorkshire (Bradford–Leeds), Western Australia, Western Isles, Westland, Whitehaven, Whitehorse, Wick, Wiltshire, Winchester, Windsor and Maidenhead, Winnipeg, Wisbech, Wokingham, Wolverhampton, Worcester, Worcestershire, Workington, Wrexham, Wrexham Qatar, Wycombe, YAMOUSSOUKRO, YAOUNDE, YAREN DISTRICT, Yaroslavl, Yellowknife, YEMEN SANA'A ZAMBIA, YEREVAN, York, Yorkshire and the Humber, Yukon, ZAGREB, ZIMBABWE, Zürich

SOP on Disposal of Non-Recoverable In-process Materials

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