preparation for Sampling Intimation slip
1.0 OBJECTIVE:
To lay down a Sampling Intimation for Process Validation / Equipment Qualification / Utility Qualification Cleaning Validation / Hold time study samples.
2.0 SCOPE:
This SOP is applicable for Sampling Intimation for Process Validation / Equipment Qualification / Utility Qualification / Cleaning validation / Hold time study samples at ………..
3.0 RESPONSIBILITY:
Officer / Executive QA
4.0 ACCOUNTABILITY:
Head QA
5.0 PROCEDURE:
5.1.1 BMR and BPR completion up to respective stage.
5.1.2 Availability of cleaned equipment’s i.e. sampling rod / spatula / Swab.
5.1.3 Personnel protective equipment’s such as nose mask and hand gloves should be used properly during any activity.
5.1.4 Availability of sampling bags along with status label.
5.1.5 Processing stage i.e. in process bulk / semi finish / finished products.
5.1.6 Product details on request intimation for in process sample / finished products.
5.2 SAMPLING FOR VALIDATION / QUALIFICATION/CLEANING/HOLD TIME ACTIVITY:
5.2.1 Sampling for Validation / Qualification activity shall be performed by the trained persons only.
5.2.2 Officer / Executive QA involved in the validation / Qualification activity shall collect the samples of in process product or material at different stages as per the sampling plan mentioned in the validation / Qualification protocol.
5.2.3 Collected samples shall be packed properly in suitable container with adequate protection for light, moisture and temperature as per requirement.
5.2.4 Executive / Officer QC shall fill the intimation slip as per their respective Annexures:
For Process validation / Hold time study for product in Annexure-I.
For Sample Intimation Slip For Qualification as per Annexure-II
For Sample Intimation Slip For Cleaning Validation as per Annexure-III
6.0 ABBREVIATIONS:
| Sr. No. | Abbreviation used | Full form of abbreviation used |
| 1. | QA | Quality Assurance |
| 2. | SOP | Standard Operating Procedure |
| 3. | Gm | Gram |
| 4. | No. | Number |
| 5. | Ltd. | Limited |
7.0 ATTACHMENTS (ANNEXES) :
Annex-I : Process validation / Hold time study for product
Annex-II : Sample Intimation Slip for Qualification
Annex-III : Cleaning validation Sample Intimation Slip
8.0 REFERENCES:
| Sr. No. | Reference Title |
| 1.0 | In house
|
Annex-I : Process validation / Hold time study for product
Annex-II : Sample Intimation Slip for Qualification
Annex-III : Cleaning validation Sample Intimation Slip
preparation for sampling Intimation slip
Online Rejection in parenteral
Receipt of Batch from Production to Packing Department
sop for for Spillage Handling in parenteral area
sop for calibration of vessels with dipstick
sop for Cleaning of Bins and Containers
cip of mixing vessel and holding vessel
sop for Cleaning of Ampoule Filling and Sealing Machine
sop for Fogging in Sterile and Non Sterile Area
sop for for Filtration of Bulk Solution
sop for fumigation in production area
sop for post cleaning after media fill
sop for cip of mixing vessel mixing mobile vessel and holding vessel
sop for De-Bagging of Three Piece Vial Dropper Caps
sop for calibration and verification of check weigher
sop for Batch number and Manufacturing and Expiry Date Coding System
standard operating procedure machine history file
sop for operation and cleaning of Hand coder
sop for Cleaning and Handling and Silicone Tubes
sop on operation and cleaning of coating pan
sop for Operation of cleaning of pipe lines
sop for operation of capsule loading machine semi automatic
sop for Machine operation capsule inspection and polishing machine
Sop batch demarcation and batch coding
sop for monitoring of reprocessing of products
sop for in-process control on liquids orals
sop for in process controls on tablets capsules packaging line
sop for Issuance retrieval and destruction of BMR and analytical records
sop for in process controls during granulation compression coating inspection
sop for Cleaning of Blister packing machine
sop for for charge hand over between the shifts
Performance requalification report of visual inspectors
sop for Cleaning and operation of ROPP caps inspection table
sop for usage and destruction of filter pad and cartridge filter
sop for cleaning and storage of transfer pipe
sop for Cleaning and operation of labeling machine
Cleaning and operation of the mono block filling and sealing machine
sop for Cleaning and operation of empty bottle inspection table
sop for Cleaning and operation of filter press
sop for cleaning and operation of liquid transfer pump and line
sop for cleaning and operation of storage vessels
sop for cleaning and operation of sugar syrup manufacturing vessel
sop for cleaning issuance and retrieval of accessories and change parts
sop for Cleaning and operation of visual inspection conveyor belt
sop for Cleaning and operation of spray gun and assemble
sop for Fogging in Aseptic and Non Aseptic Area
