1. Introduction to Batch Packing Record (BPR) of Paracetamol, Phenylephrine HCl & Cetirizine Tablets:
The Batch Packing Record (BPR) for Paracetamol, Phenylephrine Hydrochloride and Cetirizine Tablets is a controlled document used to record and verify all packing activities performed during the packaging of the finished pharmaceutical product. Each uncoated tablet contains Paracetamol IP 325 mg, Phenylephrine Hydrochloride IP 10 mg and Cetirizine Dihydrochloride IP 5 mg. The BPR provides documented evidence of packing material issuance, line clearance, overprinting verification, machine setting parameters, in-process checks, rejection analysis, packing material reconciliation and finished product yield. The record ensures that the correct product, batch number, manufacturing date, expiry date and other required details are printed accurately on the packaging materials. It also supports the identification and traceability of packing materials, monitoring of packing operations, prevention of product mix-ups and maintenance of data integrity. All packing activities must be performed according to approved procedures and documented contemporaneously by authorized personnel. Production and Quality Assurance personnel review the completed BPR to verify compliance with approved packing instructions and applicable quality requirements before final disposition of the batch.
Skip to PDF content2. Flow Diagram – Paracetamol, Phenylephrine HCl & Cetirizine Tablets:
The Batch Packing Record (BPR) documents the complete packing process of Paracetamol, Phenylephrine HCl and Cetirizine Tablets, from the issuance of packing materials to final batch release. It includes line clearance, overprinting verification, machine setup, in-process quality checks, rejection analysis, packing material reconciliation and yield calculation.
The record ensures correct product identification, packaging integrity, batch traceability and compliance with approved packing procedures. Production and Quality Assurance personnel review the completed documentation to verify that packing activities meet established quality requirements.
3. Critical Process Parameters (CPPs) and Critical Quality Attributes (CQAs) for Paracetamol, Phenylephrine HCl & Cetirizine Tablets:
Critical Process Parameters (CPPs) and Critical Quality Attributes (CQAs) are important elements of pharmaceutical manufacturing that help ensure consistent product quality, safety, and efficacy. For Paracetamol, Phenylephrine HCl and Cetirizine Tablets, CPPs include blending time and speed, compression force, tablet hardness, coating parameters (if applicable), packing conditions, environmental controls, and in-process checks. These parameters must be monitored and controlled according to approved manufacturing instructions and validated procedures to minimize variability and prevent defects.
CQAs are the physical, chemical, and microbiological characteristics that must meet established specifications to ensure the product’s quality. Important CQAs include tablet appearance, assay of each active pharmaceutical ingredient, dissolution, uniformity of dosage units, microbial quality where applicable, packaging integrity, and stability throughout the approved shelf life. The formulation contains Paracetamol 325 mg, Phenylephrine Hydrochloride 10 mg, and Cetirizine Dihydrochloride 5 mg per tablet, as stated in the product record. Effective control of CPPs helps achieve the required CQAs and supports batch-to-batch consistency. Production and Quality Assurance teams should review process records, investigate deviations, and ensure that all results comply with approved product specifications. Product-specific limits must be established through appropriate development, validation, and quality risk management activities rather than assumed from a general diagram.